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FDA
FDA Annual Reports for Approved Premarket Approval Applications
On February 7, the FDA issued a new guidance, "Annual Reports for Approved Premarket Approval Applications," which addressed the…
Health IT Advocates Prepare for Battle over Potential New FDA Safety…
The health information technology industry is gearing up for a fight against federal safety regulations according to a new report…
FDA: Medical Device Reporting Electronic Submission Requirements
Recently, the FDA released a final rule amending its postmarket medical device reporting regulation (21 C.F.R. Part 803), to…
FDA Commissioner Addresses FDASIA, DQSA, and Opioid Abuse
FDA Commissioner Margaret Hamburg testified at the Senate Health, Education, Labor and Pensions (HELP) Committee, addressing…
FDA Draft Guidance: Distributing Scientific and Medical Publications on…
A new draft guidance document released by the U.S. Food and Drug Administration (FDA) aims to clarify the ways in which a…
FDA Draft Guidance Analgesic Indications: Developing Drug and Biological…
The FDA recently released a new draft guidance with recommendations on how sponsors of analgesic painkillers should develop…
Be Careful What You “Like”: Healthcare Industry Should Consider Privacy,…
Social media offers the healthcare industry an opportunity to engage with patients, care givers, and physicians on health care…
FDA: Policies and Procedures for Proposed Trial Design Aimed at Multiple…
In a recent staff memo, Dr. Robert Temple, Deputy Director for Clinical Science at the FDA's Center for Drug Evaluation and…
US v. Caronia, One Year Later: FDA’s Position on Off-Label Promotion…
The Washington Legal Foundation (WLF) recently presented "US v. Caronia, One Year Later: The First Amendment and Federal Oversight…
FDA Office of Regulatory Affairs Operations: Outlines Significant Changes
Last September, we were the first to report on trends relating to changes in leadership at the FDA's Office of Regulatory Affairs.…