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FDA commissioner Stephen Hahn says CDER director Janet Woodcock and CBER director Peter Marks will recuse themselves from all regu...[ Price : $8.95]
Federal Register notice: FDA announces a 6/4-5 public Web conference to discuss the International Council for Harmonizations good ...[ Price : $8.95]
Karyopharm Therapeutics files a supplemental NDA for Xpovio (selinexor), indicated as a new treatment for patients with previously...[ Price : $8.95]
AdvaMed joins two national health organizations in suggesting guidelines for allowing medical device company representatives back ...[ Price : $8.95]
FDA principal deputy commissioner Amy Abernathy says the agency has an agreement with Aetion to use real-world data to research an...[ Price : $8.95]
FDA warns Indias Kumar Organic Products about CGMP violations in its production of finished pharmaceuticals.[ Price : $8.95]
Three drug industry stakeholders comment on an FDA draft guidance on developing a shared system risk evaluation and mitigation str...[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America praises an FDA draft guidance on postmarket surveillance of drugs, biologics,...