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FDA Announces Moves to Fast-Track Psychedelic Therapies

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FDA announces several actions aimed at accelerating the development of treatments for serious mental illness, following a recent e...

FDA Broadens Focus to Examine AI Use in Drug Operations: Law Firm

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A recent FDA Warning Letter signals a broader regulatory focus on how drugmakers use artificial intelligence, according to a new a...

AbbVie Gets Complete Response for Neurotoxin Candidate

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FDA issues AbbVie a complete response letter for its BLA for trenibotulinumtoxinE, an investigational, fast-acting botulinum toxin...

Incytes Niktimvo Web Site is Misleading: FDA

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FDA sends an untitled letter to Incyte Corp., warning that portions of the companys consumer-facing Web site for Niktimvo (axatili...

FDA Compliance Office Ramped Up Enforcement in 2025

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CDER's Office of Compliance releases a new annual report showing that it expanded enforcement and oversight activities in 2025.

Lonza Cited Over Manufacturing, Quality Control at Swiss Plant

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FDA raises multiple manufacturing and quality control concerns at a Swiss drug substance facility operated by Lonza Group, followi...

Global Calcium FDA-483 Has 6 Observations

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FDA releases a form FDA-483 with six observations from an inspection at Indias Global Calcium active pharmaceutical ingredient man...

Ban Mercury Amalgam Fillings: Petition

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Consumers for Dental Choice and two other advocacy groups again petition FDA to ban the use of mercury amalgams in dentistry, espe...

Gene Therapy Approved for Inherited Hearing Loss

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FDA approves a Regeneron Pharmaceuticals BLA for Otarmeni (lunsotogene parvec-cwha), the first gene therapy for a form of inherite...

FDA Not Pursuing Ban on Drug DTC Ads, Makary says

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FDA commissioner Marty Makary says the agency is not planning to eliminate direct-to-consumer pharmaceutical advertising, even as ...