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Verathon Recalls GlideScope Video Cable

[ Price : $8.95]

Verathon recalls the GlideScope Core One TouchSmart Cable due to the potential for temporary or complete loss of image when used w...

Guide on Incentives for Animal Drug Development

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Special Considerations, Incentives, and Programs to Support...

FDA Finds Deficiencies in Tricida Veverimer NDA

[ Price : $8.95]

FDA says there are deficiencies in the Tricida NDA for its veverimir to treat metabolic acidosis in patients with chronic kidney d...

Three Possible Foreign Inspection Outcomes Seen

[ Price : $8.95]

Attorney Mark Schwartz outlines three possible scenarios to resolve the current pause in FDA foreign manufacturing facility inspec...

Priority Review for Mercks Vericiguat

[ Price : $8.95]

FDA is giving priority review to a Merck/Bayer NDA for vericiguat to treat some chronic heart failure patients.

Draft on Foreign Studies in Animal Drugs

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Federal Register notice: FDA makes available a draft guidance on using data from foreign investigational studies in new animal dru...

Respirator Decontamination Webinar

[ Price : $8.95]

A CDRH Webinar discusses methods for decontaminating N95 masks for re-use and agency guidance on decontamination.

Biologics Approvals May Be at Risk: Attorneys

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Hogan Lovells attorneys say FDA authority to approve biosimilars under the BPCIA could end if the Supreme Court throws out the Aff...

Panel Delivers Mixed Vote on Mallinckrodt Kidney Drug

[ Price : $8.95]

An FDA advisory committee provides a mixed vote (8 to 7) in favor of approval for Mallinckrodts terlipressin and its use to treat ...

Clinical Computer 510(k) for Fetal Monitor

[ Price : $8.95]

FDA clears a Clinical Computer Systems 510(k) for the Obix BeCA fetal monitor.