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Right to Try Annual Summary Reporting Rule

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FDA publishes a final rule setting a new deadline for the annual summary report required under the Right to Try Law.

ISCT Criticizes Ruling in Cell, Gene Therapy Case

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The International Society for Cell & Gene Therapy says a federal court decision that FDA cannot regulate cell therapy products as ...

New OND Research Web Page

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FDA launches a new Web page to highlight CDER Office of New Drugs regulatory science research activities.

FDA Withdraws Merck NDA for Vioxx

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Federal Register notice: FDA withdraws approval of a Merck NDA for arthritis drug Vioxx (rofecoxib).

FDA Report on Generic Drug Approval Cost Savings

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An FDA report says generic drug approvals in 2018-2020 led to billions of dollars in savings.

FDA in Pistoia Alliance Working Group

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CDER representatives will participate in an In Vitro Pharmacology working group being assembled by Pistoia Alliance.

User Fee Reauthorization Talks Continue

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Congressional negotiations on FDA user fee reauthorization are continuing, with some major changes in play, according to Politico....

Medtronic Recalls Electromyogram Endotracheal Tubes

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Medtronic recalls its Xomed NIM Contact Reinforced Electromyogram (EMG) Endotracheal Tube and the NIM Standard Reinforced EMG Endo...

Inspection Form 483 for Alvotech Released by FDA

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FDA releases the FDA-483 citing 13 observations that were at the center of an Alvotech-received complete response letter on its bi...

FDA Denies Petition on Colonoscopy Preparation

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FDA denies a Braintree citizen petition that asked it not to approve a tablet-based or tablet-containing colonoscopy preparation u...