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Eli Lilly plans to submit an NDA for Ultra Rapid Lispro in 2019 after reporting favorable clinical trial data from two Phase 3 tri...[ Price : $8.95]
Federal Register notice: FDA issues a draft guidance entitled The Special 510(k) Program.[ Price : $8.95]
Federal Register notice: FDA issues an order to debar Richard M. Fleming for 10 years from providing services in any capacity to a...[ Price : $8.95]
FDA warns N-Molecular about CGMP violations in its production of PET drugs.[ Price : $8.95]
FDA posts a guidance entitled Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.[ Price : $8.95]
FDA issues a guidance with recommendations for selection of appropriate package type terms and appropriate discard statements for ...[ Price : $8.95]
Researchers suggest a change in FDA reporting requirements for exception from informed consent clinical trials to better describe ...[ Price : $8.95]
The Justice Department says Amerisource Bergen is paying $625 million to resolve three whistleblower suits claiming that it operat...