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Comments Sought on IRB Recordkeeping Requirements Extension

[ Price : $8.95]

Federal Register Notice: FDA asks for comments on a submission to OMB seeking to extend the recordkeeping requirements for institu...

FDA Extends Comment Period on MDUFA Reauthorization

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Federal Register Notice: FDA extends the comment period for the Medical Device User Fee Amendments reauthorization draft recommend...

Pfizer Scraps Cholesterol Drug on Disappointing Study Results

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Pfizer says it will discontinue its global clinical development program for bococizumab, an investigational proprotein convertase ...

Califf: Base Clinical Trials on Data Sources

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FDA commissioner Robert Califf says that data sharing will be the next big scientific revolution.

Large Molecule Drug Trials Take Longer: Analysis

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KMR Group says its analysis of clinical trial times shows that trials for large molecule drugs take longer than those for small mo...

FDA Accepts Ariad NDA for Lung Cancer

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FDA accepts for review an Ariad Pharmaceuticals NDA for brigatinib, an investigational oral anaplastic lymphoma kinase inhibitor f...

Appeals Court Asked to Overturn Flonase Case Ruling

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Washington Legal Foundation and the National Association of Manufacturers ask the 3rd Circuit Appeals Court to reject a Pennsylvan...

FDA Status Report on NDA/BLA Postmarketing Requirements

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Federal Register Notice: FDA makes available an annual report on the status of postmarketing requirements and postmarketing commit...

Comments Extended on GLP Proposed Rule

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Federal Register Proposed Rule comment extension: FDA extends the comment period for an 8/24 proposed rule to amend the regulation...

Guide on Female Sterilization Implant Labeling

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Federal Register Notice. FDA makes available a guidance on Labeling for Permanent Hysteroscopically Placed Tubal Implants Intended...