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PharmTech2h
CMC and Analytical Gaps in CRLs: Why They Persist Despite FDA Guidance and How You Can Position Yourself for Success
Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...
Houston-based Empower Pharmacy’s drugs raised red flags for FDA and other states, but not Texas
Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.
Que.com on MSN13h
AI in FDA Drug Approvals Sparks Controversy Over Fabricated Studies
In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...
The FDA Is Using an AI to "Speed Up" Drug Approvals and Insiders Say It's Making Horrible Mistakes
Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...
Sarepta drops as report suggests FDA needs new trials for Elevidys
Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...
100 days into the job, FDA head talks to CNN about agency goals— and Coke’s switch to sugar
Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...
GoodRx on MSN21h
New medications coming soon: Here’s what’s been FDA approved in 2025 so far
GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...