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Workshop on Disease Progression Models

[ Price : $8.95]

Federal Register notice: FDA announces an 11/19 public workshop entitled Best Practices for Development and Application of Disease...

Courts Forcing FDA to Reconsider Orphan Drug Designation: Analysis

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Two Hyman, Phelps attorneys explain the orphan drug designation issues facing FDA in light of appeals court decisions against the ...

ANDA Approval Withdrawal Notice Corrected

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Federal Register notice: FDA corrects a notice in the 6/25 Federal Register that announced the approval withdrawal of 36 ANDAs fro...

Info Collection on Compounding Outsourcing Facilities

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Federal Register notice: FDA seeks comments on an information collection extension entitled Obtaining Information to Understand Ch...

Info Collection on User Fee Payment Forms

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Electronic User Fee Payment Request Forms ...

3 Drug Firms Pay $447 Million Over Price Fixing

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Generic drug makers Taro Pharmaceuticals, Sandoz and Apotex agree to pay $447 million to resolve alleged False Claims Act violatio...

De Novo Rule Clarifies Device Inspections

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A new FDA final rule on the medical device de novo marketing pathway clarifies earlier language contained in the proposed rule to ...

OMB Approves 23 FDA Information Collections

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Federal Register notice: FDA announces that 23 information collections have been approved by OMB.

Teva Shuts Plant, Recalls Drugs Over Sterility

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Teva Pharmaceuticals temporarily stops production at its Irvine, CA manufacturing facility after a recent FDA inspection cited man...

Communicating Cybersecurity Best Practices

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FDA posts a document entitled Best Practices for Communicating Cybersecurity Vulnerabilities to Patients.