Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 15 May 2023
Drug companies are minting billions on unproven treatments with FDA shortcut
15 May 2023 - Accelerated approvals have helped get promising therapies to market fast — but follow-up research to confirm that ...
Posted by Michael Wonder on 22 Apr 2023
Mifepristone: US Supreme Court preserves abortion drug access
22 April 2023 - The US Supreme Court has preserved access to a commonly used abortion pill, ruling the drug ...
Posted by Michael Wonder on 20 Apr 2023
FDA approval processes for therapeutic drugs must be improved
18 April 2023 - The FDA’s glacial pace at reviewing and approving new drugs has an enormous opportunity cost for ...
Posted by Michael Wonder on 13 Apr 2023
Blocking FDA approval of abortion pill could stifle innovation in the biopharma industry, experts say
13 April 2023 - If courts affirm US District Judge Matthew Kacsmaryk’s decision to suspend the FDA’s approval, it could make ...
Posted by Michael Wonder on 11 Apr 2023
Abortion ruling could undermine the FDA’s drug approval authority
10 April 2023 - Legal scholars say the ruling by a Texas judge, if upheld, could spur disputes over many medications ...
Posted by Michael Wonder on 10 Apr 2023
Health care regulators’ outdated thinking will cost American ives
10 April 2023 - In a matter of months, ChatGPT has radically altered our nation’s views on artificial intelligence—uprooting old ...