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Alkermes asks FDA to amend its draft bioequivalence recommendations for risperidone intramuscular injection (Janssens antipsychoti...[ Price : $8.95]
CDER Office of New Drug Quality Assessment acting director Christine Moore says that while quality-by-design principles have been ...[ Price : $8.95]
Federal Register Notice: FDA denies a request from Bruce I. Diamond for a hearing and is debarring him from providing services to ...[ Price : $8.95]
Federal Register Notice: FDA reopens the comment period on a draft guidance entitled Frequently Asked Questions About Medical Food...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Medical Device Development Tools.[ Price : $8.95]
A new HHS study recommends that the Office for Human Research Protections provide a forum to IRBs and principal investigators for ...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion says that a Web page for US WorldMeds Revonto misleadingly says it is superior to othe...[ Price : $8.95]
United Therapeutics asks FDA not to allow ANDAs for generic Remodulin injection that carve out important safety information.