DBR Reg Sci - Volume 10 Issue 2 (April - September 2010) - Life Sciences, Biotechnology & Nanotechnology

Publication of the Pharmaceutical Practice Group of DBR's Government & Regulatory Affairs Department Focusing on Regulatory Science News for the Pharmaceutical, Biotech and Medical Device Industries.

US & FDA DEVELOPMENTS

On 2 September 2010, FDA's Office of Device Evaluation released their annual performance report for the 2009 fiscal year (http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM223893.pdf).
On 31 August 2010, FDA launched of a new organizational performance management system FDA-TRACK (http://www.fda.gov/AboutFDA/Transparency/track/default.htm), to monitor over a 100 program offices to better inform the public how the agency performs and satisfies its key objectives in safeguarding public health. The public will be able to access the performance records on the data.gov website by the end of the year. Press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm224401.htm
On 19 August, the HHS announced it would put $2 billion toward improving the nation's ability to respond to health threats such as emerging infectious diseases, pandemics, and bioterrorism. The new strategy stems from a review (The Public Health Emergency Medical Countermeasures Enterprise Review https://www.medicalcountermeasures.gov/documents/MCMReviewFinalcover-508.pdf) of the government's system to produce medical countermeasures such as medications, vaccines, equipment, and supplies needed in case of a health emergency. As part of the new strategy, HHS said it would make a "significant investment" to provide FDA scientists with the resources to more quickly analyze new discoveries and provide a clear regulatory pathway for products to reach the market. Press release: http://www.hhs.gov/news/press/2010pres/08/20100819a.html
On 5 August FDA announced the availability for public comment of a two-volume set of documents Center for Devices and Radiological Health Preliminary Internal Evaluations,'' which is comprised of 510(k) Working Group Preliminary Report and Recommendations and Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations, available at: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm220272.htm. Submit comments to FDA Docket FDA-2010-N-0348 by 1 November 2010 (http://www.regulations.gov). Press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm221166.htm; Q&A: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm221069.htm
On 4 August, FDA released the Prescription Drug User Fee rates for Fiscal Year 2011. The fee rates apply from October 1, 2010 through September 30, 2011. http://edocket.access.gpo.gov/2010/pdf/2010-19116.pdf
In July, FDA joined the Tox21 collaboration, joining the EPA, the National Institute of Environmental Health Sciences National Toxicology Program (NTP) and the National Institute of Health Chemical Genomics Center (NCGC). The Tox21 collaboration merges federal agency resources (research, funding and testing tools) to develop ways to more effectively predict how chemicals will affect human health and the environment. The collaboration was established in 2008 to develop models that will be able to better predict how chemicals will affect humans. http://epa.gov/ncct/Tox21/
On 11 June, FDA announced that CDER and CBER have established a public docket to provide an opportunity for interested parties to share information, research, and ideas on the FDA indexing process (see: http://edocket.access.gpo.gov/2010/pdf/2010-14047.pdf). CDER and CBER are indexing certain categories of information in product labeling for use as terms to search repositories of approved prescription medical product structured product labeling. The FDA has previously identified pharmacologic class as a top priority for indexing of product labeling information and is now announcing that medical product indications is another category of product labeling information that the agency has identified as a high priority for indexing. Submit comments to FDA Docket FDA-2010-N-0256 by 10 August 2010 (http://www.regulations.gov).
On 2 June, FDA issued a Drug Safety Communication (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213836.htm) regarding the recommended use of longacting beta-agonists (LABAs).
On 24 May, NIH and FDA launched a new website (https://www.safetyreporting.hhs.gov) that will facilitate electronic safety reporting of pre- and post-market safety data to the federal government. The new site, called the Safety Reporting Portal (SRP), features four different features for different categories of reporting: reportable food registry, pets, animal drugs, and biomedical clinical trials. In the future, the site will expand to encompass other types of clinical trials and, eventually, safety problems arising from products regulated by a broad array of federal agencies. (FDA Press Release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm213221.htm)
On 21 May, FDA announced the availability of FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration, available at: http://www.fda.gov/downloads/AboutFDA /WhatWeDo/FDATransparencyTaskForce/TransparencyReport/GlossaryofAcronymsandAbbreviations/UCM212110.pdf. The report includes 21 draft proposals about expanding disclosure of information by the agency while maintaining confidentiality of trade secrets and individually identifiable patient information. Some of the draft proposals may require extensive resources to implement and some may require changes to regulations or legislation. Background material may be found at http://www.fda.gov/transparency.
On 11 May, FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) launched the "Bad Ad Program" (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm) to help health care providers detect and report misleading prescription drug promotion.
On 26 April, FDA announced changes regarding expert panel review and discussion of data and information during pubic hearings for premarket approval (PMA) devices. As of May 1, 2010 panels will vote by ballot, and not by hand, on the safety and effectiveness of a device and its risk versus its benefit instead of on the approvability of the PMA. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209791.htm
Through a grant awarded by the U.S. EPA, University of Maine's Center on Aging completed the first statewide mail-back pilot program for managing pharmaceutical waste from consumers. EPA is currently evaluating the potential risks associated with pharmaceuticals and personal care products on public health and aquatic life. The program included the use of mailers to return unused and unwanted medications, both prescription and over-the-counter, from households. (http://www.epa.gov/aging/RX-report-Exe-Sum/)

USP

Documents recently released by USP:

Mandate and focus of new committees (for the 2010-2015 cycle) http://www.usp.org/pdf/EN/aboutUSP/expertCommitteeFocusAreas.pdf
Composition of new Committees: http://www.usp.org/pdf/EN/aboutUSP/governance/2005_2010ExpCommList.pdf
Report of the previous committee's activities: http://www.usp.org/pdf/EN/members/COEReport.pdf
New recommendation on labeling: http://vocuspr.vocus.com/vocuspr30/ViewAttachment.aspx?EID=2WSh2u7neSpIu2bXW1HJ5VQ48HGFAOGH1NdNBeuPwJE%3d
2010 USP Convention Membership Meeting http://www.usp.org/meetings/convention/

WORLD NEWS

In April 2010, Health Canada submitted a proposal before the Canadian Parliament to help cover the ballooning cost of regulating devices and drugs. http://www.hc-sc.gc.ca/dhp-mps/finance/costs-couts/fee-propo-frais-eng.php
The EMA and FDA are seeking potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. Companies that have submitted in parallel two equivalent marketing authorisation applications for the same medicinal product to both the EMA and the FDA can request to participate in the pilot programme for joint pre-approval inspection should such an inspection be considered necessary by both agencies.
- The overall objective is to see whether greater international collaboration can help to distribute inspection capacity allowing more manufacturing sites to be monitored and reducing unnecessary duplication.
- Companies can also participate in the pilot exercise by hosting a single join re-inspection (routine surveillance) where both the EMA and the FDA have separately planned routine surveillance inspections (reinspections) to take place within a similar time period at a manufacturing site of a medicinal product authorised in the USA and centrally authorised in the European Union.
- Companies that wish to participate should contact either gmp@ema.europa.eu and/or CDERInternationalGMP@fda.hhs.gov.

RECENT RULES AND GUIDELINES

FDA

FDA announced the availability of the following guidances:

On 9 August, FDA published on its website a list (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm221671.htm) of questions and answers about good manufacturing practices for the holding and distribution of drug products. The online document provides information about human-drug recalls, including details about the FDA's authority and manufacturers' responsibilities.
On 6 August, FDA published a Question and Answer guidance http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm221671.htm to emphasize the authoritative legal actions the Agency will take as part of its aggressive stance against noncompliance.
On 3 August final guidance Label Comprehension Studies for Nonprescription Drug Products (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM143834.pdf) The guidance provides recommendations on the design of label comprehension studies that can be used to assess the extent to which consumers understand the information conveyed by proposed nonprescription drug product labeling. This guidance finalizes the draft guidance published on May 1, 2009.
On 3 August Residual Drug in Transdermal and Related Drug Delivery Systems (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM220796.pdf) The draft guidance provides recommendations to developers and manufacturers of transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patch products regarding use of an appropriate scientific approach during product design and development—as well as during manufacturing and product lifecycle management—to ensure that the amount of residual drug substance at the end of the labeled use period is minimized. The draft guidance is applicable to INDs, NDAs, ANDAs, and supplemental new drug applications (sNDAs) for TDDS, TMDS, and topical patch products. Submit comments to FDA Docket FDA- 2010-D-0246 by 1 November 2010 (http://www.regulations.gov)
On 25 June 2010 CMC Postapproval Manufacturing Changes Reportable in Annual Reports (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM217043.pdf). The draft guidance provides recommendations to holders of NDAs and ANDAs regarding the types of changes that may be reported in annual reports. Specifically, the draft guidance describes CMC postapproval manufacturing changes that the FDA has determined will likely present minimal potential to have adverse effects on product quality and, therefore, may be reported by applicants in an annual report. (The draft guidance excludes positron emission tomography (PET) drug products.) Submit comments to FDA Docket FDA-2010-D-0283 by 22 September 2010 (http://www.regulations.gov).
On 17 June 2010 CDER Data Standards Plan Version 1.0 (draft plan) (http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmis%20sionRequirements/ElectronicSubmissions/UCM214120.pdf) The draft plan identifies key objectives for a data standards program at CDER, processes to be developed to ensure successful use of those standardized data and a set of recommended projects to begin in calendar year 2010. Submit comments to FDA Docket FDA-2010-N-0279 by 15 September 2010 (http://www.regulations.gov)
On 11 June 2010 Bioequivalence Recommendations for Specific Products (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072872.pdf) The guidance describes a new process for making available recommendations on how to design product-specific bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs are able to access BE study guidance on the FDA web site. The FDA believes that making the information available on the Internet will streamline the guidance process and will provide a meaningful opportunity for the public to consider and comment on product-specific BE study recommendations.
On 5 May, FDA announced the availability of a publication containing modifications that the Agency is making to the list of standards for use in premarket reviews (http://edocket.access.gpo.gov/2010/pdf/2010-10562.pdf). The revised list of FDA recognized consensus standards will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
On 22 April Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM209201.pdf). The draft guidance expands transparency, and consequently increase Agency credibility, regarding financial conflicts of interest for members of the scientific advisory panels convened to provide expert advice to the Agency on significant scientific, technical, and policy matters. Commissioner Hamburg's Letter: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm209001.htm
On 1 April, FDA issued a direct final rule (http://edocket.access.gpo.gov/2010/pdf/2010-7193.pdf), effective 16 August 2010, this August, requiring device manufacturers to include additional data in Premarket Approval (PMA) applications on pediatric patients who suffer from the disease or condition that the device is intended to treat, diagnose, or cure, even if the device is intended for adult use. The provisions require PMA applications, Humanitarian Device Exemption (HDE) applications and PMA supplements for new intended uses to include readily available information on any pediatric subpopulations that suffer from the disease or condition treated by the sponsor's device as well as information on the number of pediatric patients who might be treated with the device.
On 29 March FDA issued finalized guidance Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for Prescription Drug Packages (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM206075.pdf)

EMA

EMA Released for Public Consultation:

Questions and Answers on Guideline on the environmental risk assessment of medicinal products for human use comments due 30 September 2010 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/07/WC500094588.pdf
Guideline on the Investigation of Drug Interactions; comments due 31 October 2010 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/05/WC500090112.pdf
Paediatric addendum to CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension; comments due 30 November 2010 http://www.ema.europa.eu/pdfs/human/ewp/21397210endraft.pdf
Efficacy Working Party guidance: Concept paper on the need for a Guideline on the use of Subgroup Analyses in Randomised Controlled Trials http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/05/WC500090116.pdf
Efficacy Working Party guidance: Concept paper on the Need to Develop an Appendix to the Guideline on Bioequivalence Regarding the Presentation of Biopharmaceutical and Bioanalytical Data in Application Dossiers http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/05/WC500090113.pdf

EMA Released for Information:

EMA's Benefit-Risk methodology project. Description of the current practice of benefit-risk assessment for centralized procedure products in the EU regulatory network http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/04/WC500089603.pdf
- "At present, there are no common definitions on the concepts of benefits and risks and no formal guidance on the process of their balancing. As a result, interviewees, between agencies and within the same agency, expressed divergent views on the meaning of benefits and risks, and on their weighing. Especially with regard to risks, there was a great variance of responses. Most notably, the uncertainty of realising a benefit from the use of a pharmaceutical product was frequently mentioned as a risk."
- Among the EMA's recommendations is the establishment of a four-fold qualitative model:
  
  Favourable effects
  
  Uncertainty of favourable effects
  
  Unfavourable effects
  
  Uncertainty of unfavourable effects
FDA announced the availability of several draft guidance prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
3 September 2010
- Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 11: Capillary Electrophoresis General Chapter Annex 11 Capillary Electrophoresis General Chapter: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194492.pdf
- Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 12 Analytical Sieving General Chapter: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194501.pdf
2 April 2010
- Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in ICH Regions - Annex 7: Dissolution Test General Chapter" http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm085366.pdf
- Q4B Evaluation and Recommendation of Pharamacopoeial Texts for Use in the ICH Regions - Annex 9: Tablet Friability General Chapter http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM176888.pdf
9 April 2010
- Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 10: Polyacrylamide Gel Electrophoresis General Chapter http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM176889.pdf

ICH

On 5 May, FDA released a Q&A Document Q8, Q9, and Q10 Questions and Answers (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM210822.pdf). The guidance reflects the current working procedure of the ICH Quality Implementation Working Group for implementing the Q8, Q9, and Q10 guidances.

ISO

ISO has developed a final draft revision of its standard Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice, available at: http://www.iso.org/iso/catalogue_detail.htm?csnumber=45557 which includes more detailed requirements for risk management and device malfunction reporting, as well as an expanded definition for adverse events.
On 20 May 2010 Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM212798.pdf) The guidance document describes how FDA's CDRH and CBER are implementing the following provision of the law:

"(F) For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality system standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods."

GHTF

Earlier this year, GHTF issued a final guidance Clinical Investigations (http://www.ghtf.org/documents/sg5/sg5_n3_2010.doc). The primary purpose of the guidance is to provide guidance in relation to: 1) when a clinical investigation should be undertaken for a medical device to demonstrate compliance with the relevant Essential; and 2) the general principles of clinical investigation involving medical devices.

PQG

The PQG Guide to Supply Chain Risk Management for the Pharmaceutical and Medical Device Industries and their Suppliers, is now available at: http://www.pqg.org/publications/riskmanagement/index.php

Health Canada

On 19 April, Health Canada announced proposed changes to the Therapeutic Products Directorate's (TPD) List of Recognized Standards for medical devices.
- TPD Guidance Document on Recognition and Use of Standards under the Medical Devices Regulations (http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_standards_im_ld_normes-eng.php)
- Current List of Recognized Standards (http://www.hc-sc.gc.ca/dhp-mps/md-im/standards-normes/md_rec_stand_im_norm_lst-eng.php)
On 5 March, Health Canada published a guidance document Information and Submission Requirements for Subsequent Entry Biologics (SEBs) http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2010-eng.pdf). SEBs consist of biological drugs (proteins, antibodies and other products derived from biological sources) which are similar to previously approved biological drugs.

World Health Organization

On 14 June, the World Health Organization released its first-ever guidance The WHO Model Formulary for Children (http://www.who.int/entity/selection_medicines/list/WMFc_2010.pdf). on how to use more than 240 essential medicines for children under 13. For the first time medical practitioners worldwide have access to standardized information on the recommended use, dosage, adverse effects, and contraindications of these medicines for use in children. A number of individual countries have developed their own formularies over the years, but until now there was no single comprehensive guide to using medicines in children for all countries.

US LEGISLATION

During the week of September 13, the U.S. Senate is expected to vote on an amendment to the food safety bill (S. 510), which bans the use of the chemical bisphenol-A, or BPA, a component of some plastics, in children's products nationwide. Despite of more than 10 years of extensive research, government health officials still cannot decide whether BPA is safe. Government recently funded 10 grants under the economic Recovery Act to study BPA, and researchers are hoping to generate a definitive answer to this perplexing question. (http://thomas.loc.gov/)
On 3 August Senator Michael Bennet (D-CO) introduced S. 3690, the Drug Safety and Accountability Act of 2010, which is designed to improve regulatory oversight of drug-manufacturing facilities and improve related quality standards and monitoring. (http://thomas.loc.gov/)
On 14 July, Edolphus Towns (D-New York) Chair of the Committee on Government and Reform, introduced a House bill (HR 5740), granting FDA mandatory recall powers for adulterated or misbranded drugs, as well as drugs posing a threat to public health. (http://thomas.loc.gov/)
On 20 September, Representatives John D. Dingell, Henry A. Waxman, Frank Pallone, and Bart Stupak released a discussion draft of legislation (http://energycommerce.house.gov/documents/20100920/DRUGS-SAFE_05_xml.pdf) to provide FDA with the authorities and funding it needs to regulate what is now a global marketplace for drugs. The discussion draft builds on H.R. 759, the Food and Drug Globalization Act, which was introduced by Dingell, Pallone and Stupak last year.

MEETINGS

Information from Recent Meetings

A review of RDD 2010 is available online at http://www.rddonline.com/rdd2010. The PQRI Workshop: Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products recording can be viewed at: http://www.rddonline.com/education/pkworkshop.php.
Prescription Drug User Fee Act (PDUFA) Public Meeting on 12 April. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm117890.htm
FDA Public Meeting: Risk Evaluation and Mitigation Strategy (REMS) Public Meeting on 27-28 July 2010. http://www.fda.gov/Drugs/NewsEvents/ucm210201.htm
FDA Public Workshop Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors on 24-25 June 2010. http://www.fda.gov/Drugs/NewsEvents/ucm214703.htm
FDA Public Workshop: Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development 24 June 2010 http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm212831.htm
Materials from 16 August FDA Science Board Meeting (http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/ucm198503.htm)

Upcoming FDA Public Hearings/Meetings

The Past, Present, and Future of FDA Human Drug Regulation: A training course offered by FDA with continuing education (CE) credit for pharmacists, physicians, and nurses. The program gives health care professionals, industry, consumers, and all other interested participants an overview of the human drug regulatory process in the United States. CE Credit available through June 28, 2013. Course time: approximately 90 minutes http://www.fda.gov/Training/ForHealthProfessionals/ucm209538.htm
Tentative Schedule of 2010 FDA Advisory Committee meetings: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm153468.htm
FDA Public Workshop: Medical Device User Fee Program Public Meeting on 14 September in Hyattsville, MD (http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm218250.htm)
FDA Public Meeting: Generic Drug User Fee on 17 September in Rockville, MD (http://www.fda.gov/Drugs/NewsEvents/ucm224121.htm). The purpose of the meeting is to gather stakeholder input on the development of a generic drug user fee program.
FDA Public Workshop: Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations on 23 September. (http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm222591.htm)
FDA Public Workshop: Design of Clinical Trials of Aerosolized Antimicrobials for the Treatment of Cystic Fibrosis on 23-24 September in Silver Spring, MD (http://www.fda.gov/Drugs/NewsEvents/ucm205809.htm)
Development and Distribution of Patient Medication Information for Prescription Drugs on 27-28 September at FDA White Oak Campus to obtain input on a new framework for development and distribution of patient medication information, which is provided to patients who are prescribed drug products. http://www.fda.gov/Drugs/NewsEvents/ucm219716.htm.
CDER's Small Business Assistance Educational Forum: The Investigational New Drug (IND) Process on 8 October in Silver Spring, MD (http://www.fda.gov/Drugs/NewsEvents/ucm221605.htm)
FDA is hosting its first Medical Devices Technology Innovation Partnership (MD-TIP) Project effort on 26 October in Silver Spring. (http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm224407.htm)
FDA Public Hearing: Approval Pathway for Biosimilar and Interchangeable Biological Products on 2-3 November in Silver Spring, MD (http://thehill.com/images/stories/blogs/biosimilars.pdf).
FDA "Safe Use Initiative" workshop on 16-17 November in Silver Spring, MD (http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm#meeting).

Other Upcoming Meetings

DIA 46th Annual Meeting 13-17 June in Washington, DC (http://www.diahome.org/diahome/FlagshipMeetings/home.aspx?meetingid=20751).
8th International Aerosol Conference 29 August - 3 September at the University of Helsinki, Finland (http://www.iac2010.fi).
UK-PharmSci 2010: The Science of Medicines 1-3 September in University Park, UK (http://www.ukpharmsci.org/)
2010 PDA/FDA Joint Regulatory Conference - The New Paradigm: Quality and Compliance in Merging and Emerging Cultures 13-16 September in Washington, D.C. http://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/2010-PDAFDA-Joint-Regulatory-Conference.aspx
iSmithers Leachables & Extractables for Pharmaceutical Products 2010 14-15 September in London, UK (http://www.ismithers.net/conferences/XLE10/)
30th Annual Symposium and Exhibition Conference by the Sea on 15-17 September in Ocean City, MD http://www.conferencebythesea.net/index.html
European Respiratory Society Annual Congress 18-22 September in Barcelona, Spain (http://www.erscongress2010.org/)
FDA/Industry Statistics Workshop on 20-22 September in Washington, DC (http://www.amstat.org/meetings/fdaworkshop/index.cfm?fuseaction=program)
Meeting on Lactose as a Carrier for Inhalation Products 26-28 September in Parma, Italy (http://www.tefarco.unipr.it/ita/eventi_det.php?idEvento=91)
The ICH Quality Implementation Working Group (Q-IWG) Presents: Official Integrated Implementation Training Workshops for ICH Q8, Q9 and Q10 on 6-8 October in Rockville, MD (www.ISPE.org/2010ICHWorkshops)
ISAM/IPAC-RS European Bioequivalence Workshop 12-13 October in Frankfurt Germany (www.ipacrs.com) (See flyer on Page 13 for more details)
DIA: Maternal and Pediatric Drug Safety Symposium on 13-14 October in Bethesda, MD (http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23874&eventType=Meeting)
Devices for Drug Delivery Conference on 19 October and Medical Plastics Conference on 20 October in Copenhagen, Denmark (http://www.hexagon.dk/)
2010 RAPS Annual Conference: Succeed in the Global Regulatory Landscape on 24-27 October in San Jose, CA (http://www.raps.org/personifyebusiness/default.aspx?tabid=1556)
FIP 2010 Pharmaceutical Science World Congress in association with AAPS' Annual Meeting and Exposition November 8-12 and 14-18 in New Orleans, LA (http://www.pswc2010.org/).
InformaLifeSciences 9th Annual European Partnerships and Latest Innovations in Drug Delivery 23 -24 November in Brussels, Belgium (http://www.informaglobalevents.com/event/ddp)
PQRI-FDA Workshop on Process Drift: Detection, Measurement, and Control in the Manufacture of Pharmaceuticals on 1-3 December in Bethesda, MD (http://www.pqri.org/workshops/index.asp)
56TH AARC International Respiratory Congress on 6-9 December in Las Vegas, NV (http://www.aarc.org/education/meetings/congress/advance_program/)
Drug Delivery to the Lungs DDL 21 on 8-10 December in Edinburgh, Scotland (http://ddlconference.org.uk/)
- EPAG - SPONSORED ½ Day Workshop on The Abbreviated Impactor Measurement (AIM) And Efficient Data Analysis (EDA) Concepts in Inhaler Testing on 8 December (http://ddlconference.org.uk/index.php?q=EPAG_Workshop)
IPAC-RS 2011 Conference: Bringing Value to the Patient in a Changing World 29-20-31 March 2011 in Rockville, MD (http://www.ipacrs.com/2011%20Conference.html) CALL FOR POSTERS: Submit abstracts by 15 October. See page 2 for details. Preliminary Program: http://www.ipacrs.com/PDFs/IPACRS%202011%20Conference/Preliminary%20Program.pdf.
Pharmaceutical and Medical Packaging 2011 - "PMP'11" on 3-4 May 2011 in Copenhagen, Denmark (http://www.hexagon.dk/)
RDD Europe 2011 on 3-6 May 2011 in Berlin, Germany (http://www.rddonline.com/rdd/rdd.php?id=6)
- IPAC-RS Cascade Impaction Symposium on 6 May 2011
ISAM Congress 2011 on 18-22 June 2011 in Rotterdam, Netherlands in 2011 (http://www.isam2011.com).
RDD 2012 on 13-17 May 2012 in Phoenix, Arizona (http://www.rddonline.com/rdd/rdd.php?id=7) Speaker abstracts due 1 August 2011; poster abstracts due 13 January 2012.

REFERENCE LIBRARY

FDA Guidances

Comprehensive List of CDER Guidance Documents: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079645.pdf
New/Revised/Withdraws List of CDER Guidance for 2010: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079655.pdf
Web location where CDRH will post a list of guidance documents CDRH is considering for development: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109196.htm
Orange Book Search http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
Orange Book: April 2010: Additions and Deletions to the Drug Product List http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM211803.pdf
Orange Book: Current Cumulative Supplement http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM086233.pdf
Guidance for Industry: Newly added Bioequivalence Recommendations http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm
National Drug Code Database http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm

US Approvals and Related Information

CDRH list of approved premarket approval applications (PMAs): http://www.fda.gov/cdrh/pmapage.html
Complete List of Currently Approved NDA and ANDA Application Submissions: http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/NewDrugApplicationsNDAs/UCM149972.pdf
CBER list of approved premarket approval applications (PMAs): http://www.fda.gov/cber/products.htm
Complete List of Licensed Products and Establishments: http://www.fda.gov/BiologicsBloodVaccines/ucm133672.htm
PMA Safety and Effectiveness Summaries: http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-59.pdf
Drug Master Files: http://www.fda.gov/cder/dmf/index.htm
Standard Costs for Components of the Process for the Review of Human Drug Applications: http:// www.fda.gov/cder/pdufa/pdufa_costs.htm " Inspection of Medical Device Manufacturers: http://www.fda.gov/cdrh/comp/guidance/7382.845.pdfversion.html
FDA Recognized Consensus Standards Database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm

Other Regulatory Information

FDA publishes quarterly files from its Adverse Event Reporting System (AERS), at: http://www.fda.gov/cder/aers/extract.htm. The published data go back as far as January 2004.
Rulemaking History for Nonprescription Products: http://www.fda.gov/cder/otcmonographs/rulemaking_index.htm
Information on RFID: http://www.fda.gov/cdrh/rfid/
FDA Acronyms and Abbreviations Search: http://www.fda.gov/cder/acronyms/acronyms_about.htm
Drug Master Files: http://www.fda.gov/cder/dmf/index.htm
Dissolution Methods Database (updated) http://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm
FDA Online Tutorial is available: An Introduction to the Improved FDA Prescription Drug Labeling: http://www.fda.gov/cder/learn/CDERLearn/prescriptionLabeling/default.htm.
Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book http://www.fda.gov/cder/orange/default.htm
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated): http://www.fda.gov/cder/pediatric/BpcaPrea_full_review.htm
Drug interactions: http://www.fda.gov/cder/drug/drugInteractions/default.htm
Guidance for Industry: M2: eCTD Specification Questions and Answers and Change Requests: Companion Document: Current Q & As and Change Requests: http://www.fda.gov/cder/guidance/6339cover.htm
FY 2008 PDUFA Performance Report: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/FinancialReports/PDUFA/UCM208501.pdf
Postmarket Requirements and Commitments http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm

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Favourable effects	Uncertainty of favourable effects
Unfavourable effects	Uncertainty of unfavourable effects

United States: DBR Reg Sci - Volume 10 Issue 2 (April - September 2010)