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Princeton BioMeditech OTC Covid Test Authorized

[ Price : $8.95]

FDA issues Princeton BioMeditech an emergency use authorization for its Covid-19 Antigen Rapid Test for Home Use.

Lilly Issued 483 on Aseptic Operations

[ Price : $8.95]

FDA issues Eli Lilly a three-item Form FDA-483 after aseptic processing deficiencies were identified during a 10/2022 inspection.

FDA Science Forum Set for 6/14

[ Price : $8.95]

Federal Register notice: FDA announces a 6/14 public workshop entitled FDA Science Forum 2023.

Medtronic Next-Gen Micra Pacemakers Approved

[ Price : $8.95]

FDA approves a Medtronic PMA for its Micra AV2 and Micra VR2 next-generation miniaturized, leadless pacemakers.

Comments Sought on CMC Data Submissions

[ Price : $8.95]

Federal Register notice: FDA seeks comments on the draft document entitled Pharmaceutical Quality/Chemistry Manufacturing and Cont...

Guide on Gene Therapy Nonclinical Info

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance for industry entitled S12 Nonclinical Biodistribution Considerations...

Guide on Smoking Cessation Products

[ Price : $8.95]

FDA releases a final guidance entitled Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy (NRT) Dr...

Comments on Data/Tech Strategic Plan

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Federal Register notice: FDA extends the comment period associated with a 4/13 notice requesting feedback on the FDA Data and Tech...

DTC Research to Examine Treatment Tradeoffs

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CDERs Office of Prescription Drug Promotion proposes a direct-to-consumer drug advertising survey to understand the tradeoffs made...

FDA Approves Pfizers Prevnar 20 for Infants

[ Price : $8.95]

FDA approves Pfizers Prevnar 20 (20-valent pneumococcal conjugate vaccine) for the prevention of invasive pneumococcal disease cau...