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FDA releases a final guidance titled Incorporating Voluntary Patient Preference Information (PPI) Over the Total Product Life Cycle.

latest-news

The Washington Times publishes an opinion piece that draws attention to growing criticism of FDA commissioner Marty Makary.

LATEST NEWS

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FDA Guide on Patient Preferences in Device Submissions

FDA releases a final guidance titled Incorporating Voluntary Patient Preference Information (PPI) Over the Total Product Life Cycle.

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Editorial Criticizes Makary Over Leadership Decisions

The Washington Times publishes an opinion piece that draws attention to growing criticism of FDA commissioner Marty Makary.

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Medtronic Wins Expanded Clearance for AXiS System

Medtronic wins 510(k) clearance for its Stealth AXiS surgical system in cranial and ear, nose and throat procedures.

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FDA Grants Accelerated Approval to Rocket’s Gene Therapy

FDA gives Rocket Pharmaceuticals an accelerated approval for its gene therapy Kresladi (marnetegragene autotemcel) for children with severe Leukocyte Adhesion Deficiency-I.

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Animal Drugs

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medical-devices
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Enforcement, Advertising Oversight Shape Regulatory Landscape: Legal Update

A legal update from ArentFox highlight several emerging regulatory and enforcement developments at FDA thatare expected to have significant implicatio...

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...

Biologics

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medical-devices
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FDA Grants Accelerated Approval to Rocket’s Gene Therapy

FDA gives Rocket Pharmaceuticals an accelerated approval for its gene therapy Kresladi (marnetegragene autotemcel) for children with severe Leukocyte ...

medical-devices
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Ocugen Reports Positive Phase 2 Data for Vision Loss Gene Therapy

Ocugen announces positive 12-month results from a mid-stage clinical trial of its experimental gene therapy OCU410, aimed at treating geographic atrop...

medical-devices
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Pfizer, Valneva to File BLA for Lyme Disease Vaccine

Pfizer and Valneva plan to submit a BLA for their investigational Lyme disease vaccine candidate based on data demonstrating more than 70% efficacy in...

medical-devices
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Uncertainty for Gene Therapy, Rare Disease & Vaccines in Prasad Exit Wake

CBER director Vinay Prasad’s departure at the end of next month raises questions across the biotechnology sector about how the agency’s approach to va...

FDA General

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medical-devices
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Editorial Criticizes Makary Over Leadership Decisions

The Washington Times publishes an opinion piece that draws attention to growing criticism of FDA commissioner Marty Makary.

medical-devices
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More Conflict of Interest Transparency Needed: GAO

The Government Accountability Office recommends that FDA take steps to publicly disclose how it resolves conflict of interest and appearance issues fo...

medical-devices
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Experts Urge 32 FDA Transparency Reforms in New JAMA Viewpoint

Public health experts call for sweeping reforms to improve FDA’s transparency, arguing that longstanding gaps in disclosure persist despite recent pro...

medical-devices
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FDA Updates Guidance on Pyrogen and Endotoxin Testing

FDA posts an updated version of its guidance on pyrogen and endotoxin testing, offering manufacturers of drugs, biologics, and medical devices greater...

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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 Flags Manufacturing/Labeling Violations at STAQ Pharma Ohio Facility

FDA sends an untitled letter to STAQ Pharma of Ohio, citing significant manufacturing, quality contr...

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Podcast Explains New Bayesian Methods Trial Guidance

On a CDER guidance recap podcast, master mathematical statistician James Travis explains a new draft...

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FDA Considering Industry PDUFA 8 Incentive Proposal

FDA meeting minutes say agency representatives in the 2/26 PDUFA 8 reauthorization discussion agreed...

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GDUFA Research Helped Product-Specific Guidances: Report

The FY 2025 report on GDUFA-funded science and research tells how the research supported the develop...

Marketing

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Influencers’ Drug Promotions Pose Public Health Risks: JAMA

A new study published in JAMA Network Open highlights growing public health concerns over prescripti...

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Hims & Hers Super Bowl Ad Hit

The Institute for Safe Medicines calls on FDA, the Federal Trade Commission, and the Department of J...

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FDA DTC Ad Crackdown Raises Legal Issues: Attorneys

Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer pr...

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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...

Medical Devices

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FDA Guide on Patient Preferences in Device Submissions

FDA releases a final guidance titled Incorporating Voluntary Patient Preference Information (PPI) Ov...

motusgi
Read More
Medtronic Wins Expanded Clearance for AXiS System

Medtronic wins 510(k) clearance for its Stealth AXiS surgical system in cranial and ear, nose and th...

motusgi
Read More
FDA Flags Recall of Erbe Flexible Cryoprobes Over Rupture Hazard

Erbe USA recalls its flexible cryoprobes due to their potential to rupture during activation, which ...

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Multiple Violations at Longhorn Vaccines and Diagnostics

FDA warns Bethesda, MD-based Longhorn Vaccines and Diagnostics about Quality System, Medical Device ...