Items Tagged with 'FDA'

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Commercial IRB Disputes FDA Warning Letter

The Patient Advocacy Council, a Alabama-based commercial institutional review board (IRB), is disputing an FDA warning letter accusing it of failing to protect "economically and educationally disadvantaged subjects" in clinical trials it oversaw. Read More

Agency Turns Down Merck's Arcoxia

The FDA has issued a not approvable letter for Merck's Vioxx successor Arcoxia, telling the company it will require additional data to support the risk-benefit profile of the drug. Read More

FDA Says It Can Approve Follow-On Biologics

The FDA released a white paper saying it has the ability to approve follow-on biologics without extensive clinical trials, although some trials would be necessary for the follow-ons to replace original products. Read More