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February 29, 2016
The program is intended to provide support to ongoing efforts in rare disease product development.
February 18, 2016
The agency published guidance on immunogenicity-related considerations for low molecular weight heparin.
February 17, 2016
The agency is continuing CDER’s Regulatory Project Management Site Tours and Regulatory Interaction Program.
February 12, 2016
FDA cracks down on makers of products extracted from Cannabis and says the products cannot be considered dietary supplements.
February 10, 2016
There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.
February 08, 2016
Stephen Ostroff published a blog on FDA regarding goals to modernize the generic drug review process in an effort to increase patient access to generics.
FDA officials said on Feb. 5, 2016 that Celltrion’s biosimilar to infliximab was “highly similar” to Johnson & Johnson’s (J&J) Remicade, according to a report by Reuters.
February 03, 2016
The author reviews FDA's final Animal Rule guidance.
February 02, 2016
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
February 01, 2016
CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.