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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Laura Koman ordered by Published Date Descending.
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1
EMA Consultation On The Revised Policy On Access To Documents
The EMA has launched a public consultation on the proposed revision to its policy on access to documents.
European Union
18 Apr 2017
2
GCP Renovation ICH Reflection On "GCP Renovation"
The aim is to proceed with initiating needed renovation work as soon as practical, for example, within the next year.
United States
18 Apr 2017
3
Cures Corner: FDA Launches Regenerative Medicine Advanced Therapy Designation Program
In late January 2017, FDA took the first steps to implement certain provisions of the 21st Century Cures Act, signed into law on December 13, 2016, by launching a new designation program for regenerative medicine therapies.
United States
13 Apr 2017
4
The Continuing Story Of Manufacturers' Off-Label Promotion Of Approved Or Cleared Medical Products
Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products.
United States
13 Apr 2017
5
U.S. Senators Request President Obama To Further China's GMO Approvals
Both the United States and China agreed during the JCCT to "further cooperation and discussions regarding import requirements related to food safety."
Worldwide
23 Dec 2016
6
California's Sonoma County Bans GMO Crops
On November 8, 2016, voters in Sonoma County, California approved 86,050 to 67,758 the "Sonoma County Transgenic Contamination Prevention Ordinance".
United States
21 Nov 2016
7
EMA Updates Organizational Structure
It is not anticipated that interactions between stakeholders and the Agency will be affected by these changes.
European Union
29 Sep 2016
8
EMA Consults On Development Of Medicines To Treat Tuberculosis
The guidance is an addendum to EMA's guideline on the evaluation of medicines to treat bacterial infections.
European Union
29 Sep 2016
9
EMA Consults On Modeling And Simulation In The Development And Regulatory Review Of Medicines
EMA has published a draft guideline to support and guide the use of innovative modeling and simulation approaches that are currently being used during the development of medicines.
European Union
29 Sep 2016
10
Proposals To Revise Guidance On First-In-Human Clinical Trials
EMA is proposing changes to current guidance on first-in-human clinical trials with the aim of improving strategies to identify and mitigate risks to trial participants.
European Union
28 Sep 2016
11
EMA Publishes Report On Adaptive Pathways Pilot Project
EMA has published a final report on the experience gained during its pilot project on adaptive pathways, a product development concept for medicines that address patients' unmet medical needs.
European Union
28 Sep 2016
12
European Commission Publishes Revised Medical Device Guidance On Stand-Alone Software
The European Commission has published a revised version of its Guidelines on Qualification and Classification of Stand-Alone Software ("MEDDEV 2.1/6"), which replaces the earlier 2012 version.
European Union
28 Sep 2016
13
New EMA Guidance On Data Integrity
EMA has released new good manufacturing practice guidance aimed at ensuring the integrity of data generated in the process of testing, manufacturing, packaging, distributing, and monitoring medicines.
European Union
28 Sep 2016
14
UK's MHRA Launches FakeMeds Campaign With Warning On Diet Pills
The campaign provides practical information on how to recognize legitimate online retailers of medicines and medical devices.
UK
27 Sep 2016
15
French ANSM Issues Guidance On Pilot Phase Clinical Trials
The purpose of the pilot phase is to ensure that France is ready when the European Regulation comes into force.
European Union
27 Sep 2016
16
EMA Workshop On Genetically Modified T-Cells
People interested in participating are invited to register using the form available on the website.
European Union
27 Sep 2016
17
New EMA Guidelines On Good Pharmacovigilance Practices
The GVP guidance was effective on August 16, 2016.
European Union
27 Sep 2016
18
FDA To Host Public Conference On Key Aspects Of Drug And Device Regulations
The meeting will be available via webcast, but there will not be a transcript available following the meeting.
United States
27 Sep 2016
19
FDA Proposes Expanding Scope Of Clinical Investigator Disqualification In Regulations For New Animal Drugs For Investigational Use
With this proposal, FDA intends to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.
United States
27 Sep 2016
20
FDA Proposes Revising Regulations For Good Laboratory Practice For Nonclinical Laboratory Studies
A GLP Quality System will provide the appropriate framework for building quality into a nonclinical laboratory study and will result in more reliable data for FDA to consider when making regulatory decisions.
United States
27 Sep 2016
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