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Marks Sees Breakout Year in Gene Therapy Approvals

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CBER director Peter Marks says he expects 2024 to be a big year for gene therapy approvals as several Center initiatives take hold...

Questions on Topical Ophthalmic Draft Guide

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Four stakeholders update comments on the latest version of an FDA draft guidance on topical ophthalmic products.

Significant CGMP Violations at Amman Pharmaceutical

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FDA warns Amman, Jordan-based Amman Pharmaceutical Industries about CGMP violations in its production of drugs as a contract manuf...

FDA Cant Locate UK Maker of Filthy Eye Drops

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FDA fails to locate the UK-based manufacturer of filthy eye drops, LightEyez, accused of manufacturing and distributing unapproved...

FDA Warns 2 Ophthalmic Drug Companies

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FDA warns Mamaroneck, NY-based Delsam Pharma, and Lakewood, NJ-based EzriCare about distributing adulterated and misbranded ophtha...

FDA Denies BI Parenteral Drug Petition

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FDA denies a Boehringer Ingelheim petition asking it to change its interpretation of strength for parenteral solutions under the B...

Technical Guide on Reporting Drug Amounts

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FDA posts a final guidance entitled Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide.

FDA Upping Drug Inspections in India: McMullen

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FDA India director Sarah McMullen says the agency is working to increase drug inspections in India and station additional investig...

Viking Reports Favorable Trial, Data on Obesity Drug

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Viking Therapeutics says its Phase 2 clinical trial of obesity drug VK2735, a dual agonist of glucagon-like peptide 1 and glucose-...

Alert Issued on Hologics BioZorb Markers

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FDA issues a safety alert advising patients and healthcare providers about the potential risk of serious complications with Holigi...