Remove 2012 Remove IT Remove Manufacturing Remove Specialization
article thumbnail

Biogen agrees to pay $900 million in largest FCA Settlement Ever Secured without Government’s Intervention

FDA Law Blog

district court of Massachusetts by former employee and whistleblower Michael Bawduniak in April 2012 as a qui tam action. HHS noticed an increasing trend of illegal kickbacks in connection with speaker programs and in November 2020, the Office of Inspector General issued a Special Fraud Alert on the topic. See United States ex rel.

article thumbnail

Does the Drug Shortage White Paper Fall Short?

FDA Law Blog

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”