Simplifying Global Compliance
Drugmakers and the FDA have different ideas about the proper scale for the agency’s quality metrics program. While industry supports collecting data on no more than four metrics, the FDA promises only that it will monitor no more than 16. Read More
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
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
Merck Monday 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
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