Search
Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Colleen Heisey ordered by Published Date Descending.
Links to Result pages
 
1 2 3 4 5 6 7 8 9 10 11 . . .  
>>Next
 
Title
Country
Organisation
Author
Date
1
The FDA And Cybersecurity: How The Agency Is Addressing Cybersecurity Risks To Medical Devices
Manufacturers should be aware of, and prepare for, the actions FDA undertakes on its own initiative and as a result of the OIG recommendations.
United States
13 Mar 2019
2
FDA Draft Guidance Regarding Inclusion Of Pregnant Women In Clinical Trials
On April 3, 2018, FDA published long awaited draft guidance entitled " Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials."
United States
6 Jul 2018
3
FDA's Evolving Regulation Of Artificial Intelligence In Digital Health Products
FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence.
United States
23 Jan 2018
4
New French Decree Clarifies The Scope Of Biomedical Research
French Decree n° 2017-884 of May 9, 2017, was adopted to implement certain provisions of the Legal Ordinance of June 16, 2016, with respect to biomedical research.
France
4 Jul 2017
5
FDA Reorganizes ORA Staff
The FDA envisions that these changes will result in a high level of technical expertise and more uniform application of the ORA's policies and processes.
United States
4 Jul 2017
6
EU Medical Device Regulation 2017/745 And In Vitro Diagnostic Regulation 2017/746
Below is a high-level summary of some of the key changes brought by the MDR and IVDR to the regulatory framework applicable to medical devices.
European Union
4 Jul 2017
7
UK's Regulator Announces Its Top Priorities In The Lead Up To Brexit
The MHRA also announced a series of measures aimed at supporting innovation and improved access.
UK
15 May 2017
8
Update On Recommendations And Initiatives Of EU Regulators Ahead Of Brexit
On April 27, 2017, the EMA held a meeting with the heads of the National Competent Authorities of the EU/European Economic Area Member States to discuss the consequences of Brexit...
European Union
12 May 2017
9
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
10
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
11
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
12
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
13
Regulatory Developments Life Sciences Companies Should Expect In The New Presidential Administration
Essential to implementation of the incoming President's agenda is the appointment of senior leaders in the executive departments and administrative agencies responsible for implementing the agenda.
United States
24 Jan 2017
14
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
15
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
16
European Commission Authorizes GMOs For Food And Feed Uses
The European Commission authorized the sale of products containing, consisting of, or produced from four related GM maizes combining three different single GM events, and six related GM maizes combining two different single GM events.
European Union
12 Oct 2016
17
EFSA To Present Draft GM Plant Allergenicity Guidance To Stakeholders
On November 23, 2016, EFSA will present its draft guidance document on allergenicity of genetically modified ("GM") plants at a meeting in Parma, Italy.
European Union
12 Oct 2016
18
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
19
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
20
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
Links to Result pages
 
1 2 3 4 5 6 7 8 9 10 11 . . .  
>>Next