Blog
RSS FeedPosted by Michael Wonder on 02 Nov 2023
FDA notes “continued growth” of Orbis collaborative review program, adds EMA as observer
1 November 2023 - There has been “continued growth” in the number of applications submitted to Project Orbis, and the ...
Posted by Michael Wonder on 11 Oct 2023
FDA establishes new advisory committee on digital health technologies
11 October 2023 - Today, the US FDA announced the creation of a new Digital Health Advisory Committee to help ...
Posted by Michael Wonder on 16 Sep 2023
FDA’s final breakthrough devices guidance now includes technologies that address health disparities
15 September 2023 - Final guidance on the US FDA breakthrough device program includes new language noting that the program ...
Posted by Michael Wonder on 13 Sep 2023
FDA proposes changes to key approval pathway for medical devices, five years after promising
12 September 2023 - Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, ...
Posted by Michael Wonder on 30 Aug 2023
FDA issues final guidance on considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products
30 August 2023 - Today, the US FDA issued a final guidance for industry titled Considerations for the Use of Real-World ...
Posted by Michael Wonder on 16 Aug 2023
In a rare move, FDA threatens to fine a company for failing to report clinical trial results
16 August 2023 - For only the fifth time, the FDA recently threatened to fine a company or clinical trial ...
Posted by Michael Wonder on 02 Aug 2023
Changes in the number of continuation patents on drugs approved by the FDA
1 August 2023 - Brand name pharmaceutical manufacturers often sustain high prices in the US by obtaining patents that delay generic ...
Posted by Michael Wonder on 01 Aug 2023
Stakeholders want clearer terms in FDA's generally accepted scientific knowledge guidance
31 July 2023 - Drug makers and research groups are generally supportive of the US FDA’s plan to allow greater flexibility ...
Posted by Michael Wonder on 28 Jul 2023
CDER collaborates with global regulators on pharmaceutical quality assessments and inspections
28 July 2023 - The FDA and the EMA recently completed the first collaborative assessment of a proposed post-approval change ...
Posted by Michael Wonder on 10 Jul 2023
Association of Advisory Committee votes with US FDA - a decision-making on prescription drugs (2010-2021)
11 July 2023 - In this qualitative study of 409 advisory committee meetings, overall, 88% of FDA regulatory actions aligned ...
Posted by Michael Wonder on 04 Jul 2023
Biomarker tests for targeted oncology therapies pose tricky regulatory challenges
29 June 2023 - The US FDA recently announced the launch of a year-long pilot programme regarding diagnostic methods within oncology ...
Posted by Michael Wonder on 21 Jun 2023
Novo Nordisk takes actions to help protect US patients from unlawful sales of non-FDA approved medicines claiming to contain semaglutide
20 June 2023 - Initiating legal proceedings against medical spas, weight loss or wellness clinics, and compounding pharmacies to cease and ...
Posted by Michael Wonder on 15 Jun 2023
New Alzheimer’s drug is a problem for FDA’s pass-fail approach
15 June 2023 - The FDA is slated to soon give full approval to Leqembi, a new medicine for Alzheimer’s disease ...
Posted by Michael Wonder on 15 Jun 2023
FDA should reject accelerated approval of gene therapy SRP-9001
15 June 2023 - The US FDA should reject the accelerated approval of the gene therapy SRP-9001 (Sarepta Therapeutics) for ...
Posted by Michael Wonder on 16 May 2023
The decline of science at the FDA has become unmanageable
15 May 2023 - Before 1962, US federal law did not require pre-marketing proof of effectiveness for drugs. But senate hearings ...