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Info Collection on Device De Novo Requests

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Federal Register notice: FDA seeks comments on an OMB information collection extension entitled De Novo Classification Process (Ev...

Invivyds Pemgarda Gets EUA for Covid

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Federal Register notice: FDA announces the issuance of an emergency use authorization for Invivyds Pemgarda (pemivibart) for use a...

Ostar Beauty Selling Unapproved Medical Devices: FDA

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FDA warns Chinas Ostar Beauty Sci-Tech about illegally marketing unapproved medical devices.

Multiple Violations in Lengthy Biomic Inspection

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FDA warns Charlottesville, VA-based ION Intelligence of Nature about multiple violations in its production of drugs and dietary su...

Spinearts Scarlet Anterior Cervical Cage Cleared

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FDA clears a Spineart 510(k) for its Scarlet AC-Ti secured anterior cervical cage.

Teva Spurns FDAs Beta-Lactam Drug Recommendation

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Teva says FDA should drop its recommendation for the use of dedicated manufacturing facilities for ezetimibe to prevent cross-cont...

ICH Pharmacoepidemiological Study Guidance Out

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FDA publishes for comment the International Council for Harmonization M14 guidance on general principles for planning, designing, ...

Sanofi Sarclisa sBLA Accepted for Priority Review

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FDA accepts for priority review a Sanofi supplemental BLA for Sarclisa (isatuximab) in combination with standard of care for treat...

Workshop on Patient-Generated Health Data

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FDA co-sponsors a 6/26-27 public workshop on using patient-generated health data in medical device development.

Platform Technology Designation Guidance

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FDA publishes a draft guidance on the drug development platform technology designation program.