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The American Academy of Pediatrics says FDA should deny a Merz North America citizen petition seeking six months pediatric exclusi...[ Price : $8.95]
The European Compliance Academy online GMP newsletter says three 2014 Warning Letters to drug or API manufacturers included IT fin...[ Price : $8.95]
Otsuka asks FDA not to accept for substantive review an Alkermes NDA for a long-acting form of Otsukas Abilify.[ Price : $8.95]
FDA approves an Orexigen Therapeutics NDA for Contrave for chronic weight management in people on a reduced-calorie diet and under...[ Price : $8.95]
A team of five FDA inspectors begins an inspection of Sun Pharmas Halol facility in Gujarat, India, the same facility tied to seve...[ Price : $8.95]
Duchesnay asks FDA to improve specific bioequivalence conditions on any ANDA sponsor for generic Diclegis.[ Price : $8.95]
Three stakeholders express general support for an FDA draft guidance on the informed consent information sheet and raise questions...[ Price : $8.95]
Public Citizen asks FDA to not allow recent advisory committee members to act as hired guns for companies and speak before their f...