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A federal appeals court has raised the bar for whistleblowers filing False Claims Act (FCA) suits against drugmakers, saying they must provide specific information about the fraudulent claims made, not just broad allegations about a drugmaker’s conduct. Read More
To correct one of the most common problems that sidetracks ANDA submissions, the FDA recommends bioequivalence studies for most drugs submitted as ANDAs should use a two-period, two-sequence, single-dose, crossover study design. Read More
The FDA issued a Form 483 to Biogen Idec that cites a weakness in the way the company manages suppliers, highlighting the difficulties drugmakers continue to have with supplier quality issues. Read More
OTC drugmaker AmeriDerm Laboratories has a long history of failing to test its Paterson, N.J., plant’s water supply for objectionable microorganisms, the FDA says. Read More
Lawmakers want the FDA to explain how hackers broke in to the CBER online submission system to steal personal user information and what the FDA has done to prevent a recurrence. Read More
A bipartisan federal budget deal reached Dec. 10 removes the threat of sequestration hanging over fiscal 2014 and 2015 FDA user fees, and would ensure they aren’t locked away along with some of last year’s payments. Read More
Merck Dec. 9 offered to pay out $27.7 million to settle nearly 1,200 personal injury lawsuits claiming its osteoporosis drug Fosamax caused jaw-bone deterioration known as osteonecrosis of the jaw (ONJ). Read More
HHS has approved the overhaul of the FDA’s Office of Generic Drugs (OGD), allowing the agency to move most of its functions relating to generic drugs under one roof. Read More
A group of pharmaceutical representatives has recommended 10 product and site quality metrics that the FDA should consider collecting from manufacturers, helping the agency shape its new quality metrics program. Read More