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FDA
AdvaMed Releases Innovation Agenda: Proposes Device Tax Repeal; Automatic…
The Advanced Medical Technology Association (AdvaMed) on February 10th released a comprehensive set of policy proposals…
FDA Brief Summary and Adequate Directions for Use: Disclosing Risk…
FDA: Advertisements “should focus on the most important risk information rather than an exhaustive list of risks.”
Over the…
FDA Commissioner Margaret Hamburg To Resign in March, Writes Farewell…
Dr. Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), has resigned, and will leave the agency at…
Biosimilars: FDA Calls For Comment on Data Needed To Show a Product is…
2015 is poised to be a big year for biosimilars. For starters, FDA owes industry more guidance on “interchangeability” and the…
How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols…
Late last year, the FDA released draft guidance for the pharmaceutical industry entitled "How to Obtain a Letter from FDA Stating…
Report Finds “Conflicts of Interest” Have No Effect on FDA…
Stringent conflicts-of-interest policies keep many experts off of FDA advisory committees. A new study suggests that the fear of…
FDA Device Guidance: General Wellness: Policy for Low Risk Devices
The Food and Drug Administration set an ambitious guidance schedule for itself this year. On January 20, the Center for Devices…
FDA Device Guidance: Medical Device Accessories: Defining Accessories and…
The Food and Drug Administration set an ambitious guidance schedule for itself this year. On January 20, the Center for Devices…
21st Century Cures Initiative Introduces Significant Legislative Proposal
In April 2014, Energy and Commerce Committee Chairman Fred Upton (R-MI) partnered with Rep. Diana DeGette (D-CO) to launch the…
Duke Cardiologist Robert Califf Named FDA Deputy Commissioner
FDA Commissioner Margaret A. Hamburg, M.D., on Tuesday appointed Robert Califf, M.D., a recognized global leader in…