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High-Risk Issue With Angiographic Syringes in Surgical Kits: FDA

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FDA issues an early alert warning healthcare providers about a potentially dangerous defect in certain angiographic syringes inclu...

FDA, CMS Unveil RAPID to Speed Device Coverage Decisions

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FDA and CMS unveil a new joint initiative aimed at significantly shortening the time it takes for innovative medical devices to re...

Agency Rejects Grace Therapeutics GTx-104 NDA

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FDA sends Grace Therapeutics a complete response letter rejecting approval for its experimental treatment GTx-104 (nimodipine), ci...

Loper Bright Affecting Regulation of Synthetic Biology: Column

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A Clinical Trial Vanguard column demonstrates how synthetic biology is outstripping FDAs regulatory framework under the Supreme Co...

Revive Rx FDA-483 Has 5 Repeat Observations

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FDA releases the form FDA-483 with five repeat observations from an inspection at Houston, TX-based Revive Rx Pharmacy.

4 Ways to Better Use CRISPR-Edited Therapies: Article

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Researchers describe FDA and congressional actions that will improve the ability of the new plausible mechanism pathway to lead to...

Reject Cipla NDA for Descovy Duplicate: Gilead

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Gilead calls on FDA to rescind its decision to file a Cipla 505(b)(2) NDA for an apparent duplicate of Gileads Descovy.

Warning Letter to Firm Over Weight-loss/Diabetes Drugs

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FDA issues a Warning Letter to New Life Pharma citing serious manufacturing and regulatory violations tied to the companys product...

FDA extends review for Sanofis subcutaneous Sarclisa

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FDA extends by three months its review of a Sanofi BLA for a subcutaneous formulation of Sarclisa (isatuximab-irfc) for use in com...

2 Vet4U Inspection Observations

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FDA releases the form FDA-483 issued following an inspection at the Vet4U drug distribution facility in Clay, NY.