Pew Charitable Trusts health care products director Liz Richardson says CDRH should increase transparency by requiring more and better information on ...
FDA approves Medtronic expanded indications for its Freezor and Freezor Xtra Cardiac Cryoablation Focal Catheters for treating pediatric atrioventricu...
An independent review of FDAs user fee program for biosimilars finds that first-cycle approval rates were higher during the first four years of the cu...
Federal Register notice: FDA sends to OMB an information collection revision entitled Investigational New Drug Application Regulations 21 CFR part 31...
Federal Register notice: FDA sends an information collection revision on medical device Class 2 special controls for human immunodeficiency virus sero...
FDA schedules a 3/22 virtual public meeting to discuss its final assessment of the BsUFA Program for Enhanced Review Transparency and Communication.
FDA announces the publication of 30 new and 13 revised product-specific guidances to promote generic drug development.
Jones Day attorneys outline Sen. Thom Tillis request for an independent study of data on drug companies using the patent system to delay competition a...