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Drug/Device User Interface MAPP

[ Price : $8.95]

CDER issues a MAPP outlining the roles and responsibilities of the Office of Generic Drugs and Office of Surveillance and Epidemio...

Legislation to Expand Affordable OTC Birth Control

[ Price : $8.95]

Lawmakers introduce a bill to ensure access to over-the-counter oral birth control drugs.

Apply Covid Lessons to Other Diseases: Drug Companie

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Global Forum representatives from 12 major drug companies call for a Covid-19-like approach to therapies for other significant dis...

AAM Issues with FDA Quality Metrics Program

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The Association for Accessible Medicines says it is concerned that FDA does not have statutory authority for its proposed quality ...

Bill to Tighten Device Signal Communications

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Sens. Marshall and Braun propose legislation to limit how FDA communicates medical device safety information.

Dupixent Approved for Pediatric Atopic Dermatitis

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FDA approves Sanofis Dupixent (dupilumab) for children aged six months to five years with moderate-to-severe atopic dermatitis who...

Outlook Therapeutics Refiling BLA in September

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Outlook Therapeutics says it has withdrawn a BLA submitted in March for Lytenava (bevacizumab-vikg) for treating wet age-related m...

Accreditation Body Participation in ASCA Pilot

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FDA posts information on accreditation body participation in the Accreditation Scheme for Conformity Assessment pilot program.

Allogene Therapeutics Gets FDA RMAT Designation

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FDA grants Allogene Therapeutics a regenerative medicine advanced therapy designation for ALLO-501A in relapsed/refractory large B...

Medtronic Pump Implant Kit Recall is Class 1

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FDA says a Medtronic recall of its HVAD pump implant kit due to a pump weld defect is Class 1.