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Aptalis Pharma files a citizen petition seeking to block approval of generic versions of Canasa (mesalamine) rectal suppositories,...[ Price : $8.95]
FDA approves a Valeant Pharmaceuticals NDA for Luzu (luliconazole) Cream, 1% for topical treatment of athletes foot, jock itch and...[ Price : $8.95]
Federal Register Notice: FDA plans participation in the Medical Device Single Audit Program International Coalition Pilot Program.[ Price : $8.95]
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Federal Register Notice: FDA reopens the comment period on a draft guidance entitled Frequently Asked Questions About Medical Food...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Medical Device Development Tools.