Regulatory Affairs

Pharma Whistleblowers Need Solid Proof, Appeals Court Rules

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

FDA Recommends BE Study Designs in ANDA Guidance

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

Merck Offers $28M to Settle Fosamax ONJ Suits

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