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FDA
FDA: Draft Guidance for Industry Fees for Human Drug Compounding…
The US Food and Drug Administration (FDA) has published a new guidance document intended to establish user fees to fund…
FDA Proposed Rule: Medical Device Classification Procedures
As recently reported, the U.S. Food and Drug Administration (FDA) is proposing to simplify the way it classifies and reclassifies…
FDA Proposes Expedited Approval Process for Medical Devices
The US Food and Drug Administration (FDA) proposed a new program to expedite medical device approvals for patients whose serious…
FDA Finalizes Public Availability of Advisory Committee Members’ Financial…
The Food and Drug Administration (FDA) announced a new conflict of interest guidance entitled Public Availability of Advisory…
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FDA Draft Guidance: Distributing Scientific and Medical Publications on…
A new draft guidance document released by the U.S. Food and Drug Administration (FDA) aims to clarify the ways in which a…
FDA Draft Guidance Analgesic Indications: Developing Drug and Biological…
The FDA recently released a new draft guidance with recommendations on how sponsors of analgesic painkillers should develop…