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Device GMPs Harmonized with International Standards

[ Price : $8.95]

FDA issues a final rule to amend the medical device GMP requirements of the Quality System regulation to harmonize and modernize t...

Abeona Pz-Cel BLA Moving Forward

[ Price : $8.95]

FDA has completed a bioresearch monitoring inspection and mid-cycle review meeting for the Abeona Therapeutics BLA for pz-cel.

Four FDA-483s Released

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FDA releases the forms FDA-483 issued following inspections at four drug manufacturing facilities in three countries.

Final QS Rule for International Harmonization

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FDA publishes a final rule amending the medical device Quality System Regulation to harmonize it with an international standard us...

Revised Biosimilar Research Roadmap Out

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FDA releases a revised biosimilar research roadmap to help researchers develop proposals for funding under BsUFA 3.

Hearing on FDA Foreign Inspections

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The Subcommittee on Oversight and Investigations of the House Energy and Commerce Committee schedules a 2/6 hearing on shortcoming...

Biogen Abandoning Aduhelm in Alzheimers Re-focus

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Biogen discontinues the further development and commercialization of controversial Alzheimers drug Aduhelm (aducanumab-avwa) as pa...

CBER Plans 9 Additional Guidances in 2024

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CBER releases its guidance agenda for 2024 that includes a listing of topics upcoming guidances will address.

Warning on Copycat Bausch Eye Drops

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FDA issues a warning on South Moon and Rebright or FivFivGo eye drops because of potential risks for eye infections.

Clinical Study Diversity Workshop Comments

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The stakeholder trade associations praise FDA for its 11/2023 workshop on enhancing clinical trial diversity and offer additional ...