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Guidance on Unique Device Identification Database

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Federal Register Notice: FDA releases a draft guidance: Global Unique Device Identification Database (GUDID).

Companion Diagnostics Regulatory Space Evolving Rapidly: CDRH

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CDRH Office of In Vitro Diagnostics and Radiological Health personalized medicine staff director Elizabeth Mansfield says the worl...

Oxygen Bio Submits Studies on Oxygen Carrier to FDA

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Oxygen Biotherapeutics responds to an FDA clinical hold with results from two series of animal studies for its intravenous oxygen ...

FDA Orders Colored Labeling for Fentanyl Patches

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FDA orders color changes to the writing on Duragesic (fentanyl) and generic equivalent pain patches so they can be seen more easil...

Workshop on Rare Disease Product Development

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Federal Register Notice: FDA plans a public workshop 1/6-7/14: Complex Issues in Developing Drug and Biological Products for Rare ...

Despite Report, FDA Sees No Surge in Drug Recalls

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FDA counters a Stericycle ExpertRecall Report showing a 127% surge in recent drug recalls with its own data showing no such surge.

Stakeholders Seek Standardized REMS and Evaluations

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The American Pharmacists Association says FDA should continue moving to standardized Risk Evaluation and Mitigation Strategies pro...

Easier, Faster Inspections or Objective, Honest Ones?

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Editor Jim Dickinson analyzes the apparent scope of FDA commissioner Margaret Hamburgs new Program Alignment Group and sees a pote...

CDER Partially Grants/Denies Petitions on Suboxone 505(b)(2) NDAs

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CDER partially grants and denies requested actions in two citizen petitions filed by Hyman, Phelps & McNamara seeking restrictions...

CDRH Final Guidance on Mobile Medical Applications

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A final guidance says CDRH intends to focus its oversight on mobile medical applications that are intended to be used as an access...