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FDA OKs Lillys Follow-on Insulin Glargine

[ Price : $8.95]

FDA approves an Eli Lilly 505(b)(2) NDA for Basaglar, a follow-on long-acting human insulin analog indicated to improve glycemic c...

CBER Report Touts Product Approvals

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The 2015 CBER directors report says the Center accomplished many things in several areas of responsibility, including approving im...

Additional IND Safety Reporting Guidance

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FDA issues a guidance with additional information for IND sponsors on developing a systematic approach for safety reporting.

GAO Asked to Study NBCD Generic Pathway

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Members of the House Energy and Commerce Committee ask the Government Accountability Organization to study the FDA regulatory appr...

Advisors Nix New Ezetimibe Indications

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Members of the FDA Endocrinologic and Metabolic Drugs Advisory Committee vote against recommending approval of new indications for...

Judges Back Impossibility Preemption in Design Defect

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Attorneys James Beck says that the 6th Circuit has become the first appeals court to support the impossibility preemption of both ...

FDA Concedes to Pacira in First Amendment Suit

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FDA concedes and it and Pacira Pharmaceuticals settle a First Amendment challenge over alleged off-label promotion involving Expar...

CPOE Medication Safety Report Recommendations

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A Brigham and Womens Hospital Center for Patient Safety Research and Practice white paper provides findings from its analysis of c...

Comments Sought on Bar Code Labels

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Federal Register Notice: FDA seeks comments on the bar code label requirements for drug and biological products.

Guidance on Head Lice Treatment

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Federal Register Notice: FDA releases a draft guidance for industry entitled Head Lice Infestation: Developing Drugs for Topical T...