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U.S. Government Weighs in on Biosimilar Dispute

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The U.S. government steps into an ongoing Biologics Price Competition and Innovation Act dispute (Amgen v. Sandoz), contending tha...

FDA Approves CSL Behrings Privigen

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FDA approves CSL Behrings Privigen [immune globulin intravenous (human), 10% liquid] for treating adults with chronic inflammatory...

FDA Approves 1st Generic Tamiflu

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FDA approvea a Nesher Pharmaceuticals ANDA for the first generic version of Genentechs Tamiflu (oseltamivir phosphate) for oral su...

FDA Approves Broader Briviact Use in Epilepsy Patients

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FDA approves a UCB supplemental NDA for Briviact (brivaracetam) as monotherapy for partial-onset (focal) seizures in patients 16 y...

T2 Biosystems Files 510(k) for Sepsis Panel

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T2 Biosystems files a 510(k) for the T2Bacteria Panel that is designed to run on the companys T2Dx Instrument as a rapid diagnosti...

Guidance on FDA accepting Gifts on Behalf of U.S.

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Federal Register Notice: FDA makes available a guidance on Gifts to FDA: Evaluation and Acceptance.

Comments Sought on Device Pediatric Info Collection

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Federal Register Notice: FDA seeks comments on an information collection related to Medical Devices; Pediatric Uses of Devices; Re...

Guidance on CVM Blood Level Bioequivalence Studies

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Federal Register Notice: FDA makes available a guidance entitled Bioequivalence: Blood Level Bioequivalence Study.

Guidance on FDA accepting Gifts on Behalf of U.S.

[ Price : $8.95]

Federal Register Notice: FDA makes available a guidance on Gifts to FDA: Evaluation and Acceptance.

Agios Pharma Stops Drug Development After FDA Hold

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Agios Pharmaceuticals pulls the plug on its development program involving its second pyruvate kinase-R activator, AG-519, and with...