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FDA Guide on Viral Vaccine Development

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FDA releases a new guidance on developing cell-based viral vaccines, including products intended to address emerging and pandemic ...

FDA Implementing Some HRS Recommendations

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FDA commits to implementing several Heart Rhythm Society recommendations to improve implantable heart device safety.

Comments Sought on Combo Product Practices

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Federal Register Notice: FDA publishes results and seeks comments on a review of various practices related to assigning combinatio...

FDA OKs IVX Animal Health ANADA

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Federal Register Final rule: FDA approves an IVX Animal Health supplemental ANADA for a new container-size dropper bottle to admin...

New Unit Creating Disease Education Programs

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Ignite Health spins off Incendia Health Studios to develop unbranded disease education programs.

FDA Clinical Hold on UCB/Immunomedics Lupus Drug

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FDA and European regulatory authorities place a clinical hold on a UCB and Immunomedics clinical trial involving epratuzumab as a ...

Physician Cited for Research Problems

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FDA warns Florida physician Herman Zaharowitz of problems with his work as a clinical investigator.

FDA Unfazed by 2nd EU NSAID Review

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While European regulatory authorities prepare for another NSAID review of cardiovascular safety issues next month, FDA believes cu...

FDA Will Continue Combination Product Agreements

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FDA says it wont revise intercenter agreements on assigning combination products.

FDA Guidance on Reprocessed SUDs Out

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FDA issues an updated guidance for industry and FDA staff on validation data to be submitted for reprocessed single-use devices.