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Federal Register Advance notice of proposed rulemaking: FDA extends the comment period on potential changes to its regulations for...[ Price : $8.95]
Federal Register Notice: The HHS Secretary delegates authority to the FDA commissioner to determine that any clinical trial inform...[ Price : $8.95]
Federal Register Notice: FDAs Anti-Infective Drugs Advisory Committee will meet 11/28 to discuss a Janssen Therapeutics NDA for tr...[ Price : $8.95]
FDA grants priority review for a Sucampo/Takeda Pharmaceuticals sNDA for Amitiza (lubiprostone) for treating opioid-induced consti...[ Price : $8.95]
CDRH deputy director for science and chief scientist William H. Maisel pleads guilty in Maryland district court to charges of soli...[ Price : $8.95]
HHS delegates authority to FDA to police clinical trial information that is submitted to clinicaltrials.gov as required by the FDA...[ Price : $8.95]
The Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act of 2012, which strengthens criminal ...[ Price : $8.95]
FDA warns Endogastric Solutions about violations in its conduct of a clinical trial for a weight loss device.