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FDA approves an Eli Lilly 505(b)(2) NDA for Basaglar, a follow-on long-acting human insulin analog indicated to improve glycemic c...[ Price : $8.95]
The 2015 CBER directors report says the Center accomplished many things in several areas of responsibility, including approving im...[ Price : $8.95]
FDA issues a guidance with additional information for IND sponsors on developing a systematic approach for safety reporting.[ Price : $8.95]
Members of the House Energy and Commerce Committee ask the Government Accountability Organization to study the FDA regulatory appr...[ Price : $8.95]
Members of the FDA Endocrinologic and Metabolic Drugs Advisory Committee vote against recommending approval of new indications for...[ Price : $8.95]
Attorneys James Beck says that the 6th Circuit has become the first appeals court to support the impossibility preemption of both ...[ Price : $8.95]
FDA concedes and it and Pacira Pharmaceuticals settle a First Amendment challenge over alleged off-label promotion involving Expar...[ Price : $8.95]
A Brigham and Womens Hospital Center for Patient Safety Research and Practice white paper provides findings from its analysis of c...