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5 Off-label Communication Hearing Themes

[ Price : $8.95]

Mintz Levin attorneys summarize five important themes from an FDA hearing on appropriate regulation of off-label communication.

CP Pharmaceuticals Inspection Found CGMP Issues

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FDA warns CP Pharmaceuticals about CGMP violations in its manufacture of finished pharmaceuticals.

Guidance on Drug Metabolite Safety Testing

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FDA posts a guidance on Safety Testing of Drug Metabolites that provides recommendations to industry on when and how to identify a...

Petition Seeks Change on Probiotic Quantitative Labeling

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The International Probiotics Association petitions FDA asking that it amend its to require the quantitative amount of probiotic in...

FDA Untitled Letter on Unapproved Biologic

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FDA sends Antera Therapeutics an untitled letter due to promotional claims on the companys Web site that make Aralyte Starter Kit ...

Guide Revises Recommendations on Donor Eligibility for Tissues/Cells

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Federal Register Notice: FDA makes available a guidance entitled Revised Recommendations for Determining Eligibility of Donors of ...

Sanofi Discontinuing TheraCys Bladder Cancer Therapy

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Sanofi Pasteur decides to discontinue making TheraCys (BCG live attenuated), indicated for treating non-muscle invasive bladder ca...

CVM Report on Combination NADAs with Medicated Feeds

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Federal Register Notice: FDA makes available a report on a CVM working group that proposes possible changes to the current review ...

Guide on Generic Drug User Fee Questions & Answers

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Federal Register Notice: FDA makes available a guidance entitled Generic Drug User Fee Amendments of 2012: Questions and Answers R...

FDA Officials Seek Improvements in Device Feasibility Studies

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FDA officials suggest approaches to improving medical device early feasibility studies in the U.S.