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Federal Register notice: FDA seeks comments on nine bulk drug substances that it is proposing not to allow outsourcing facilities ...[ Price : $8.95]
FDA grants Concept Medical a breakthrough device designation for MagicTouch AVF, a sirolimus drug-coated balloon catheter for trea...[ Price : $8.95]
FDA grants Akari Therapeutics an orphan drug designation for nomacopan and its use in treating hematopoietic stem cell transplanta...[ Price : $8.95]
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Puma Bios Nerlynx (neratini...[ Price : $8.95]
The Trump Administration mulls FDA acting commissioner Ned Sharpless time at the agency, and without a nomination to move him into...[ Price : $8.95]
An FDA safety alert recommends that healthcare providers transition to duodenoscopes with innovative designs that are more safe an...[ Price : $8.95]
FDA issues two final guidances explaining its views on making benefit/risk determinations for certain medical device approval appl...[ Price : $8.95]
FDA issues an FDA-483 with eight observations from an inspection at Dr. Reddys drug manufacturing facility in Andhra, Pradesh, Ind...