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Info Collection on New Animal Drug Regs

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Federal Register notice: FDA seeks comments on an information collection extension entitled New Animal Drugs for Investigational U...

Praise, Suggestions for Informed Consent Guide

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Five stakeholders generally praise FDA efforts in a draft guidance on key information and facilitating understanding in informed c...

Decentralized Trials Time Has Come: Marks

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CBER director Peter Marks and Brown University medical school professor Eli Adashi say it appears that decentralized clinical tria...

NCPA Statement to FDA Compounding Session

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The National Community Pharmacists Association raises several categories of concerns with FDA in advance of the agencys annual dru...

FDA Recognizes Blood Labeling Standard

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FDA publishes a guidance recognizing the latest revision of the United States Industry Consensus Standard for the Uniform Labeling...

Final Rule on Lab-Developed Tests

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Federal Register notice: FDA publishes a final rule to amend its regulations to make explicit that in vitro diagnostic products (I...

Use Accelerated Approval for Rare Diseases: Commentary

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A National Mucopolysaccharidoses Society commentary urges FDA to use accelerated approval for promising treatments for rare diseas...

Finalize Race, Ethnicity Data Guidance: DFA

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Doctors for America calls on FDA to finalize a guidance on collecting race and ethnicity data in clinical trials and clinical stud...

Multiple Violations at Indonesias P.T. Sankei

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FDA warns Banten, Indonesia-based P.T. Sankei Medical Industries about Quality System and Medical Device Reporting violations in t...

Aquestives Diazepam Buccal Film Approved

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FDA approves an Aquestive Therapeutics ANDA for Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereoty...