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Debarment Order Against Principal Investigator

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Federal Register notice: FDA issues an order to permanently debar Martin Valdes from providing services in any capacity to a perso...

FTC Challenges Teva Orange Book Listings

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The Federal Trade Commission files an amicus brief calling out Teva Pharmaceuticals for improperly listed patents in FDAs Orange B...

Pemgarda Authorized for Preventing Covid

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FDA grants Invivyd an emergency use authorization for Pemgarda (pemivibart) and its use for pre-exposure prophylaxis of Covid-19.

FDA Settles Ivermectin Messaging Lawsuit

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FDA agrees to delete its Covid-related social media posts on ivermectin as part of a settlement after three physicians who objecte...

Clarity in RWE Guidance is Welcome: Attorneys

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An online post by attorneys from Hogan Lovells praises FDAs new draft guidance on Real-World Evidence: Considerations Regarding No...

Organon Wants Generic Nexplanon Restrictions

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Organon asks FDA to put restrictions on ANDA applications citing Organons Nexplanon as the reference-listed drug.

4 Observations in Medi-Fare Inspection

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FDA releases the form FDA-483 with four observations from an inspection at Medi-Fare, a Blacksburg, SC, outsourcing facility.

FDA Grants, Denies Draize Test Petition

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FDA grants a Center for Responsible Science petition to the extent that the agency no longer requires or recommends Draize dermal ...

AdvaMed on Metallic Coatings Characterization

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AdvaMed gives FDA a 14-page table with 44 suggested edits to a draft guidance on the characterization of metallic coatings and/or ...

Safety Labeling Changes for Fluorouracil Injection

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FDA approves safety labeling changes for fluorouracil injection products when used in patients with dihydropyrimidine dehydrogenas...