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IND-Exempt BA/BE Study Guidance

[ Price : $8.95]

FDA publishes a draft guidance on the electronic submission of expedited individual case safety reports from IND-exempt BA/BE stud...

Guide on N-Acetyl-L-Cysteine Enforcement Discretion

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Federal Register notice: FDA makes available a final guidance entitled Policy Regarding N-acetyl-L-cysteine.

Regulatory Review Period for Rozlytrek

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Genentechs Rozlytrek tablet...

FDA Permanently Debars Duniel Tejeda

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Federal Register notice: FDA permanently debars Duniel Tejeda from providing services in any capacity to a person that has an appr...

$229 Million Boost in Senate FDA Budget Bill

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The Senate Appropriations Committee posts its fiscal year 2023 proposed budget bill for FDA that increases the agencys spending by...

Accelerated Approval Program Largely Successful: Analysis

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An Amgen study says the FDA accelerated approval program is working well and should not be changed because there are some drug out...

CDRH Still Working on AL/MI Guidance: Attorneys

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Jones Day attorneys update FDAs commitments for a regulatory framework to address artificial intelligence as a tool for advancing ...

bioMrieux Kidney Injury Assay Cleared

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FDA clears a bioMrieux 510(k) for its Vidas Nephrocheck assay to detect kidney stress in patients at risk of acute kidney injury.

Priority Review for Gamidas Omidubicel

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FDA accepts for priority review a Gamida Cell BLA for omidubicel for treating patients with blood cancers in need of an allogenic ...

FDA Publishes 48 Product-Specific Guidances

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FDA publishes 48 new and revised product-specific guidances in its latest batch.