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The Senate HELP Committee offers an initial 15 recommendations for reforming FDA as part of what it says will be a collaborative, bipartisan process.

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FDA’s refusal to review Moderna’s mRNA influenza vaccine reignites concerns that vaccine policy — particularly involving mRNA technology — is becoming increasingly entangled with politics, according to a conservative advocacy group.

LATEST NEWS

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Senate HELP Committee: 15 Ways to Reform FDA

The Senate HELP Committee offers an initial 15 recommendations for reforming FDA as part of what it says will be a collaborative, bipartisan process.

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Debate Intensifies Over Politicization of mRNA Vaccines

FDA’s refusal to review Moderna’s mRNA influenza vaccine reignites concerns that vaccine policy — particularly involving mRNA technology — is becoming increasingly entangled with politics, according to a conservative advocacy group.

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FDA DTC Crackdown Reshapes Industry Creative Approach

Drug advertising consultant Bob Ehrlich says the recent wave of FDA enforcement letters on drug promotion activities is reshaping how pharmaceutical companies approach direct-to-consumer television advertising.

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Rare Disease Innovation Hub 2026 Strategic Agenda

The FDA Rare Disease Innovation Hub sets eight action items for 2026.

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Animal Drugs

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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...

medical-devices
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Sydnexis Pediatric Myopia Drug Meets Endpoints

Sydnexis says its SYD-101 drug to treat pediatric progressive myopia met both the primary and key secondary endpoints in the Phase 3 STAR trial.

Biologics

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medical-devices
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Debate Intensifies Over Politicization of mRNA Vaccines

FDA’s refusal to review Moderna’s mRNA influenza vaccine reignites concerns that vaccine policy — particularly involving mRNA technology — is becoming...

medical-devices
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Turmoil Mounts Under Prasad’s Leadership: WSJ

CBER faces mounting scrutiny after its top official, director Vinay Prasad, refused the review of Moderna’s flu vaccine application— a move that some ...

medical-devices
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CBER Head Overruled Staff on Moderna Flu Vaccine Filing

CBER director Vinay Prasad overrules the Center’s career reviewers in deciding to issue Moderna a refusal-to-file letter for its BLA for an influenza ...

medical-devices
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Inhaled Gene Therapy for Lung Cancer Gets ‘Expedited’ Status

FDA awards Krystal Biotech a Regenerative Medicine Advanced Therapy designation for KB707, an inhalable gene therapy being investigated for treating l...

FDA General

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medical-devices
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Trust in FDA and CDC Remains Low After Vaccine Changes

A new poll finds public confidence in FDA and Centers for Disease Control and Prevention remains low following recent changes to the federally recomme...

medical-devices
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FDA’s Expanding Role, Staff Cuts Challenge Oversight: GAO

A new GAO report finds FDA’s regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, and now it faces workforce reducti...

medical-devices
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Guide on Device Cybersecurity Released

FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.

medical-devices
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FDA Official’s Personal Legal Actions Trigger Ethics Probe

HHS Office of Inspector General begins an ethics investigation into FDA deputy chief of staff Samuel Doran and whether he misled the federal governmen...

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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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FDA DTC Crackdown Reshapes Industry Creative Approach

Drug advertising consultant Bob Ehrlich says the recent wave of FDA enforcement letters on drug prom...

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Rare Disease Innovation Hub 2026 Strategic Agenda

The FDA Rare Disease Innovation Hub sets eight action items for 2026.

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CGMP Issues at Australia’s Cosmetic Manufacturers Pty

FDA warns Australia’s Cosmetics Manufacturers about CGMP violations in its production of drugs as a ...

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Compass Pathways Reports 2nd Positive Trial for Depression Drug

Compass Pathways reports that its investigational psilocybin therapy met the primary endpoint in a...

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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Trividia True Metrix Glucose Monitor Early Alert

An FDA Early Alert says Trividia Health has issued updated use instructions for its True Metrix bloo...

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Medline Class 1 Recall on Malfunctioning Beds

Medline recalls (Class 1 device correction) certain Medline homecare beds as a Class I recall, warni...

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FDA Shifts to Risk-Based Device Inspections under QMSR

As part of FDA’s recent implementation of the Quality Management System Regulation, a new risk-based...

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Issues with AI-Enhanced Surgical Devices Cited

A detailed Reuters report looks at instances of surgical adverse events that may be related to artif...