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Rep. Jake Auchincloss (D-MA) criticizes FDA’s new voucher program that offers select drugmakers sharply shortened review timelines, arguing the program undermines scientific standards and the agency’s credibility.

latest-news

Acting CDER director Tracy Beth Hoeg looks to hire the petitioner behind a request the Center is considering to add new Warnings to commonly prescribed antidepressants, a move many believe is a conflict of interest.

LATEST NEWS

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Rep. Auchincloss Criticizes Commissioner’s Priority Voucher Program

Rep. Jake Auchincloss (D-MA) criticizes FDA’s new voucher program that offers select drugmakers sharply shortened review timelines, arguing the program undermines scientific standards and the agency’s credibility.

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Hoeg Recruits Petitioner Seeking New SSRI Warnings

Acting CDER director Tracy Beth Hoeg looks to hire the petitioner behind a request the Center is considering to add new Warnings to commonly prescribed antidepressants, a move many believe is a conflict of interest.

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Partial Hold on Myotonic Dystrophy Type 1 Therapy

FDA places a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.’s experimental therapy for myotonic dystrophy Type 1.

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FDA Denies Petition Seeking Accelerated Aging Therapies

FDA denies an Age Reversal Unity petition asking the agency to establish a framework and issue guidance for expedited clinical trials for aging-related therapeutics.

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Animal Drugs

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medical-devices
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Partial Hold on Myotonic Dystrophy Type 1 Therapy

FDA places a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.’s experimental therapy for myotonic dystrophy Type 1.

medical-devices
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FDA Warns Elanco Animal Health About Pradalex Ads

The Center for Veterinary Medicine warns Elanco Animal Health about false and misleading claims in promotional materials for its Pradalex that treats ...

medical-devices
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Antimicrobial Drug Duration of Use Guidance

FDA publishes a guidance with recommendations for how sponsors of animal drugs may facilitate changes to the approved conditions of use of specific ty...

medical-devices
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Sangamo Begins Rolling BLA for Fabry Gene Therapy

Sangamo Therapeutics begins a rolling BLA submission seeking accelerated approval of its experimental Fabry disease gene therapy, following result...

Biologics

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medical-devices
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Regenxbio’s Complete Response Letter Released

FDA posts a complete-response letter that outlined last month's rejection of Regenxbio’s BLA for its gene therapy clemidsogene lanparvovec.

medical-devices
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FDA Wants Randomized Trial for Huntington’s Gene Therapy

FDA recommends that uniQure conduct a randomized, double-blind, sham surgery-controlled trial before seeking BLA approval for its Huntington’s disease...

medical-devices
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Pfizer CEO Concerned About FDA Vaccines Chief

Pfizer CEO Albert Bourla tells TD Cowen healthcare conference that the leadership of FDA’s biologics center is worrisome because it disregards the rec...

medical-devices
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FDA Accepts Vanda BLA for Rare Skin Disorder Drug

FDA accepts for review a Vanda Pharmaceuticals BLA for imsidolimab, a potential new treatment for generalized pustular psoriasis.

FDA General

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medical-devices
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FDA Overhauls National Drug Codes

FDA finalizes a sweeping overhaul of the National Drug Code system, adopting a standardized 12-digit format for the identifier used to uniquely distin...

medical-devices
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Ex-FDA Leaders Accuse Trump Admin of Distorting Contraceptive Science

Three former senior FDA officials tell a federal appeals court that the Trump administration mischaracterized the science on contraceptive safety when...

medical-devices
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FDA Employees Told Not to Use Claude AI in Tech Dispute

HHS directs FDA and other health agency employees to immediately stop using the artificial intelligence platform Claude after the Trump administration...

medical-devices
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Makary Defends Approval Standards and Prasad’s Role

FDA commissioner Marty Makary defends the agency’s scientific standards and personnel, particularly CBER director Vinay Prasad, amid mounting politica...

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Federal Register

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PDUFA Public Meeting for User Fee Reauthorization

Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for...

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Generic Drug Fee Program Reauthorization Meeting

Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug ...

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FDA Withdraws and Reissues 2 Guidances

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissui...

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CDER Continues Quality Management Program

Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second ye...

Human Drugs

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Rep. Auchincloss Criticizes Commissioner’s Priority Voucher Program

Rep. Jake Auchincloss (D-MA) criticizes FDA’s new voucher program that offers select drugmakers shar...

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Hoeg Recruits Petitioner Seeking New SSRI Warnings

Acting CDER director Tracy Beth Hoeg looks to hire the petitioner behind a request the Center is con...

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FDA Denies Petition Seeking Accelerated Aging Therapies

FDA denies an Age Reversal Unity petition asking the agency to establish a framework and issue guida...

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FDA Posts Fujian Genohope FDA-483

FDA posts the form FDA-483 with six observations from a 2023 inspection at the Fujian Genohope Biote...

Marketing

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Neffy Broadcast Ad ‘False or Misleading’: OPDP

An FDA Untitled Letter cautions ARS Pharmaceutical about false or misleading claims for its Neffy na...

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Cobenfy Ad Letter Signals Tight Limits on DTC Claims: Attorneys

A December FDA violation letter targeting a schizophrenia drug advertisement from Bristol Myers Sq...

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FDA Flags AstraZeneca’s Farxiga TV Ad as Misleading

FDA cites a direct-to-consumer television advertisement for AstraZeneca’s Farxiga (dapagliflozin) ta...

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Oversight of Influencer Social Media Posts Hard: Researchers

University of Chicago researchers explain how difficult it will be to improve government oversight o...

Medical Devices

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Diasol Manufacturing Illegal Dialysis Disinfectants: FDA

FDA warns Phoenix, AZ-based Diasol, Inc., about multiple Quality System and Medical Device Reporting...

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Synergy Spine’s Artificial Cervical Disc Approved

FDA approves a Synergy Spine Solutions PMA for its Synergy Disc, a motion-preserving artificial cerv...

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Fresenius Recalls Ivenix Pumps Over Software Issue

Fresenius Kabi recalls its Ivenix Large Volume Pump due to a software issue.

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Alert on Abiomed Heart Pumps

FDA issues an early alert about a potentially high-risk problem involving certain heart pump compone...