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FDA OKs Genentechs Vabysmo Syringe

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FDA approves a Genentech Vabysmo prefilled syringe to treat three retinal disorders with the same medicine as Vabysmo vials.

FDA Drops Interchangeability Switching Studies

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Venable attorney Robert Schwartz says an updated FDA guidance with alternatives to switching studies for demonstrating biosimilar ...

CGMP Violations in Sun Pharmaceutical Inspection

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FDA warns Indias Sun Pharmaceutical Industries about repeat CGMP violations at one drug manufacturing facility and in other compan...

Opportunities, Risks in SCOTUS End to Chevron Deference: Lawyers

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Attorneys in several law firms analyze the opportunities and risks for FDA-regulated companies arising from the Supreme Court deci...

Web Site Illegally Selling Semaglutide Products: FDA

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FDA warns the ozempen.com Web site to stop offering unapproved and misbranded drugs to U.S. consumers.

FDA OKs New Lilly Alzheimers Drug

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FDA approves Lillys Kisunla injection to treat Alzheimers disease.

Plan Now to Adopt FDA Trial Diversity Guide: Lawyers

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Five Hogan Lovells attorneys analyze a new FDA draft guidance on clinical trial diversity action plans and urge companies to begin...

ICH M14 Pharmacoepidemiological Studies Guide

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FDA publishes a draft International Conference on Harmonization M14 guidance on planning, designing, and analyzing observational p...

Device Total Product Life Cycle Advisory Program Continues

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CDRH extends its Total Product Life Cycle Advisory Program to include devices reviewed in the Office of Radiological Health, the D...

Guidance on Addressing Regulated Product Misinformation

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FDA publishes a draft question-and-answer guidance to help firms address misinformation about their approved or cleared medical pr...