BTS Research Addresses FDA Warning Letter Satisfactorily
BTS Research Addresses FDA Warning Letter Satisfactorily From the desk of the President & CEO, April 1st, 2024 BTS is very pleased to have received a satisfactory completion of the findings…
Most Oncology Approvals Using Surrogate Endpoints Lack Postmarket Confirmation, Study Says
Most of the new oncology indications approved under Real Time Oncology Review (RTOR) relied on surrogate endpoints that were never confirmed as clinically effective in postmarketing trials, according to a…
FDA Sets Two Class I Recalls for SonarMed Airway Monitors, One for BioMérieux Test Kits
SonarMed Airway monitors and sensors saw two separate Class I recalls for a restricted inner diameter in the airway and software that failed to detect the partial obstruction, while BioMérieux…
FDA Continues Crackdown on Semaglutide Imposters
A recent Warning Letter to www.dashpct.com, a Malaysian online marketer, should send a clear message that the agency is getting tough on companies selling unapproved and misbranded semaglutide (Rybelsus/Ozempic/Wegovy). Source:…
FTC Targets 300 ‘Junk Patents’ With Warning Letters, Including Ozempic
The Federal Trade Commission (FTC) continues slicing a machete through the patent thicket. Source: Drug Industry Daily
Form 483 Slams Zydus for Drug Contamination, Employee Untruthfulness, and More
In a punishing one-two punch, the FDA slammed Zydus Lifesciences for the second time this month, with a 10-observation Form 483 finding — among other things — inadequately investigated glass…
Quick Notes: Draft Guidances — April 30, 2024
This edition of Quick Notes provides an overview of four recently released draft guidances on the manufacture of cell-based products and on the FDA’s enforcement policy regarding test manufacturers’ offering…
FDA Seeks Public Input on Advisory Committee Processes
The FDA is soliciting written feedback as well as presenters to speak on its use of and processes for its advisory committee during a virtual listening session scheduled for June…
J&J’s, Bristol Myers’ Challenges to Medicare Drug Price Negotiations Squashed
Big pharma again came out on the losing end of a major court battle challenging the Biden administration’s Inflation Reduction Act (IRA) drug price negotiations, as a New Jersey federal…
Final Rule Declares LDTs to Be Devices Regulated by the FDA
In the wake of Congress repeatedly trying and failing to pass the bipartisan Verifying Accurate, Leading-edge IVCT (In-Vitro Clinical Test) Development (VALID) Act, the FDA today announced its final rule…
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