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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...

High-Risk Issue With Angiographic Syringes in Surgical Kits: FDA

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FDA issues an early alert warning healthcare providers about a potentially dangerous defect in certain angiographic syringes inclu...

FDA, CMS Unveil RAPID to Speed Device Coverage Decisions

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FDA and CMS unveil a new joint initiative aimed at significantly shortening the time it takes for innovative medical devices to re...

Agency Rejects Grace Therapeutics GTx-104 NDA

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FDA sends Grace Therapeutics a complete response letter rejecting approval for its experimental treatment GTx-104 (nimodipine), ci...

Loper Bright Affecting Regulation of Synthetic Biology: Column

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A Clinical Trial Vanguard column demonstrates how synthetic biology is outstripping FDAs regulatory framework under the Supreme Co...

Revive Rx FDA-483 Has 5 Repeat Observations

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FDA releases the form FDA-483 with five repeat observations from an inspection at Houston, TX-based Revive Rx Pharmacy.

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...