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FDA General

FDA AI Inspections Prompts Industry Readiness Strategy Rethink

Former FDA enforcement official suggests new strategies for industry to prepare for agency inspections that rely on artificial intelligence tools.

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Human Drugs

Agency Defends Generic Drug Oversight

FDA officials are seeking to bolster confidence in generic medicines, highlighting the agency's oversight of drug manufacturing, inspection programs and post-market surveillance while promoting new efforts to expand domestic pharmaceutical production.

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FDA General

PhRMA Urges FDA to Clarify Digital Health Technology Standards

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Human Drugs

FDA Expands Pfizer Bleeding Drug Approval

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Medical Devices

Alert on GE HealthCare Infant Resuscitation Systems

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Human Drugs

FDA Seeks Industry Data for Kidney Biomarker Initiative

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FDA AI Inspections Prompts Industry Readiness Strategy Rethink

Former FDA enforcement official suggests new strategies for industry to prepare for agency inspections that rely on artificial intelligence tools.

motusgi
Agency Defends Generic Drug Oversight

FDA officials are seeking to bolster confidence in generic medicines, highlighting the agency's oversight of drug manufacturing, inspection programs and post-market surveillance while promoting new efforts to expand domestic pharmaceutical production.

motusgi
PhRMA Urges FDA to Clarify Digital Health Technology Standards

PhRMA calls on FDA to provide clearer regulatory expectations for the use of digital health technologies in drug development, arguing that adoption has lagged despite years of agency guidance and industry investment.

motusgi
FDA Seeks Industry Data for Kidney Biomarker Initiative

FDA launches a new effort to aggregate clinical trial data on kidney safety biomarkers, seeking pharmaceutical industry participation in a pilot program that could ultimately broaden the agency's use of a novel "biomarker incubator."

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Animal Drugs

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Open Letter to Trump Urges FDA Push on Rare Diseases

In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targeting fatal genetic diso...

medical-devices
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FDA Guide on Developing Drugs for Pulmonary Tuberculosis

FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, emphasizing the need ...

medical-devices
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White House Reportedly Moves to Oust Commissioner Makary

Several media outlets report that President Trump has signed off on a plan to remove FDA commissioner Marty Makary from his post.

medical-devices
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Atara says FDA outlined potential path for Cell Therapy Resubmission

Atara Biotherapeutics says it and partner Pierre Fabre Pharmaceuticals have received feedback from FDA outlining a potential path toward resubmitting ...

Biologics

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medical-devices
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FDA Approves Lupin's Interchangeable Lucentis Biosimilar

FDA approves a Lupin BLA for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Genentech's blockbuster eye drug Lucentis.

medical-devices
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FDA Orders Takeda to Add Boxed Warning to Adzynma

FDA orders Takeda Pharmaceuticals to strengthen the safety labeling for its rare disease therapy Adzynma, including the addition of a Boxed Warning, a...

medical-devices
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CBER Post New E-Submission Frequently Asked Questions Guide

FDA posts a new set of frequently asked questions (FAQ) aimed at helping companies navigate the electronic submission process for products regulated b...

medical-devices
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Replimune to Refile Controversial Melanoma BLA

Replimune plans to resubmit its controversial BLA for RP1 (vusolimogene oderparepvec) in combination with Opdivo as a treatment for advanced melanoma ...

FDA General

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medical-devices
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FDA AI Inspections Prompts Industry Readiness Strategy Rethink

Former FDA enforcement official suggests new strategies for industry to prepare for agency inspections that rely on artificial intelligence tools.

medical-devices
Read More
PhRMA Urges FDA to Clarify Digital Health Technology Standards

PhRMA calls on FDA to provide clearer regulatory expectations for the use of digital health technologies in drug development, arguing that adoption ha...

medical-devices
Read More
Stakeholders Press FDA to Pause Voucher Program Amid Transparency Concerns

Stakeholders at FDA's public hearing on the Commissioner’s National Priority Voucher program urge the agency to temporarily suspend the initiative and...

medical-devices
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House Passes $7.1 Billion FDA Spending Bill

The House passes FDA’s appropriations bill for fiscal year 2027 that provides $7.1 billion for the agency.

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Federal Register

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FDA Warns Brazilian Drug Maker Over Records Request

FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aer...

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FDA Delays Review Action on Alzheimer’s Drug

FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation...

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Alnylam Pharma’s Web Promo is Misleading: FDA

FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a c...

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PhRMA Urges Changes to FDA’s ‘Plausible Mechanism’ Guidance

PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that ...

Human Drugs

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Agency Defends Generic Drug Oversight

FDA officials are seeking to bolster confidence in generic medicines, highlighting the agency's over...

motusgi
Read More
FDA Seeks Industry Data for Kidney Biomarker Initiative

FDA launches a new effort to aggregate clinical trial data on kidney safety biomarkers, seeking phar...

motusgi
Read More
FDA Expands Pfizer Bleeding Drug Approval

FDA approves an expanded indication for Pfizer's hemophilia treatment Hympavzi (marstacimab-hncq), a...

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Guidance Details Post-Approval Responsibilities for Generics

FDA releases a draft guidance outlining post-approval responsibilities facing manufacturers of gener...

Marketing

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FDA Cites QOL Medical for Misleading Promotion of Sucraid

FDA issues an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease ...

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FDA Drug Ad Crackdown Leads to More Spending on TV/Streaming Ads: Report

An FDA crackdown on allegedly deceptive prescription drug advertising leads to a sharp increase in p...

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DTC Crackdown Unfazed at Post-Makary FDA: Expert

DTC Perspectives CEO Bob Ehrlich says the sudden departure of former FDA commissioner Marty Makary i...

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Brukinsa TV Ad ‘False or Misleading’: OPDP

A CDER Office of Prescription Drug Promotion Notice of Violation cites a misleading BeOne Medicine T...

Medical Devices

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Alert on GE HealthCare Infant Resuscitation Systems

FDA issues an early alert warning healthcare providers about a potentially high-risk defect affectin...

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FDA Breakthrough Device Designations Top 1,280

FDA says its breakthrough devices program has surpassed 1,280 designations since its launch, highlig...

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FDA Plans to Exempt Low-Risk Devices From 510(k) Requirements

FDA posts a guidance outlining its intent to exempt several low-risk, unclassified medical devices f...

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Early Alert on Abiomed Introducer Kits Due to Serious Injuries

FDA issues an early alert regarding a potentially high-risk problem involving certain Abiomed cathet...