Regulatory Alert: New FDA Proposed Rule — Sponsor Reporting of Falsified Data
Today the FDA has published a proposed rule in the Federal Register (75 FR 33 at 7412, 2/19/10) that will require sponsors (and defining petitioners under food/supplement submission rules as sponsors) to report to FDA any instance of falsified data that the sponsor company identifies within a proposed or current human or animal study in support of pharmaceutical, medical device, food, color...read more
