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WHO Draft Data Integrity Guidance

[ Price : $8.95]

The World Health Organization releases for comment a draft guideline on a risk-based approach to data integrity.

Transdermal, Topical Delivery System Guidance

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FDA issues a draft guidance with recommendations for applicants and manufacturers of transdermal and topical delivery systems on i...

Comments Sought on Substances for Animal Compounding

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Federal Register notice: FDA establishes a public docket for interested parties to nominate bulk drug substances or re-nominate bu...

Draft Guide on Animal Drug Compounding

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Federal Register notice: FDA makes available a draft guidance for Industry #256 entitled Compounding Animal Drugs from Bulk Drug S...

CDRH STeP Program Explanation

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CDRHer Joshua Chetta outlines provisions in a draft guidance proposing the new Safer Technology Program for Medical Devices.

Hahn Meets Praise, Resistance During FDA Confirmation

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FDA commissioner nominee Stephen Hahn sails through his Senate confirmation hearing 11/20 with praise and some resistance from law...

BLA for Thyroid Eye Disease Therapy to Panel

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Federal Register notice: FDA announces a 12/13 Dermatologic and Ophthalmic Drugs Advisory Committee meeting to discuss a Horizon ...

Panel Meeting on Durect NDA for Bupivacaine

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Federal Register notice: FDA announces a 1/16 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss a Durec...

Carestream Dual-Energy Imaging Cleared

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FDA clears a Carestream 510(k) for its Dual-Energy imaging technology and its Focus 35C Detector with Image Suite Software for med...

Apicore Wants Specific Study for Penicillamine BE

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Apicore asks FDA to require a specific bioequivalence test for ANDAs citing the companys penicillamine capsules.