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Lilly Issued 483 on Aseptic Operations

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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

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

Medtronic Next-Gen Micra Pacemakers Approved

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

Comments Sought on CMC Data Submissions

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

Guide on Gene Therapy Nonclinical Info

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

Guide on Smoking Cessation Products

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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

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

Petition Seeks Removal of Bamboos NarxCare Software

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The Center for U.S. Policy petitions FDA to deem a widely used clinical decision support software, Bamboo Healths NarxCare, a misb...