[ Price : $8.95]
FDA approves a Sanofi-aventis and Bristol-Myers Squibb supplemental NDA for a 300 mg loading dose of its Plavix for acute coronary...[ Price : $8.95]
Federal Register Final rule: FDA approves a Pfizer supplemental NADA that adds a pathogen to the indication for tulathromycin in c...[ Price : $8.95]
FDA approves an alternate manufacturing site for Akorns IC-Green.[ Price : $8.95]
FDA considers invoking forfeiture on 180-day generic drug exclusivity for pending generic applications seeking to market copies of...[ Price : $8.95]
A former FDA regulatory counsel and special agent says FDA is flying blind on important surveillance and badly needs new funding f...[ Price : $8.95]
FDAs administrative law judge reasserts $510,000 civil money penalties against TMJ Implants Inc., agreeing with CDRH that the comp...[ Price : $8.95]
Specialty Distribution Services pays $10.5 million in a deferred prosecution agreement over illegally distributing human growth ho...[ Price : $8.95]
CDRH Office of Compliance director Tim Ulatowski tells RAPS that his office will soon allow device makers to voluntarily submit IS...