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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 therapy Sucraid (sacrosidase) Oral Solution were false or misleading because they overstated the drug's benefits and omitted important risk information.

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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 Aerosol after the company failed to respond to multiple agency requests for manufacturing records.

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FDA General

Senate Committee Postpones FDA Funding Bill Consideration

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Human Drugs

FDA Accepts Roche NDA for Breast Cancer Drug

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Human Drugs

3-Year New Clinical Investigation Exclusivity Guidance Explained

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Human Drugs

FDA Accepts 1st Drug-Induced Liver Injury Tool

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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 therapy Sucraid (sacrosidase) Oral Solution were false or misleading because they overstated the drug's benefits and omitted important risk information.

motusgi
FDA Warns Brazilian Drug Maker Over Records Request

FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aerosol after the company failed to respond to multiple agency requests for manufacturing records.

motusgi
HealthPartners Neuroscience Center BIMO Issues

FDA warns St. Paul, MN-based HealthPartners Neuroscience Center Research and Innovation about good laboratory practice violations in its conduct of nonclinical laboratory studies.

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3-Year New Clinical Investigation Exclusivity Guidance Explained

Two Morgan Lewis attorneys explain a new FDA draft guidance on three-year drug exclusivity for new clinical investigations.

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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.

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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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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 ...

medical-devices
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Change FDA Sepsis Screening Strategy: Dingell and McCormick

Reps. Debbie Dingell and Rich McCormick say FDA should update its strategy for evaluating and identifying sepsis as a means to exclude inappropriate t...

FDA General

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medical-devices
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Senate Committee Postpones FDA Funding Bill Consideration

Senate appropriators delay consideration of a fiscal 2027 spending bill that would fund FDA, after a broader dispute over a Republican reconciliation ...

medical-devices
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Be Prepared for New One-Day FDA Inspections: Law Firms

Law firms Hogan Lovells and Foley and Lardner advise pharmaceutical and medical device companies to maintain full inspection readiness while FDA under...

medical-devices
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Former FDA and HHS Heads Opine on Next Commissioner

Former FDA commissioner Andrew C. von Eschenbach and former HHS secretary Tommy G. Thompson urge policymakers to prioritize leadership and institution...

medical-devices
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Report Urges FDA Overhaul for Faster Reviews

A new policy report urges sweeping FDA reforms, arguing that shortening the time required to bring drugs, biologics and medical devices to market coul...

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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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HealthPartners Neuroscience Center BIMO Issues

FDA warns St. Paul, MN-based HealthPartners Neuroscience Center Research and Innovation about good l...

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3-Year New Clinical Investigation Exclusivity Guidance Explained

Two Morgan Lewis attorneys explain a new FDA draft guidance on three-year drug exclusivity for new c...

motusgi
Read More
FDA Accepts 1st Drug-Induced Liver Injury Tool

FDA has accepted a Letter of Intent for the first in silico artificial intelligence-driven digital l...

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FDA Accepts Roche NDA for Breast Cancer Drug

FDA accepts for priority review a Roche NDA for giredestrant, an investigational oral endocrine ther...

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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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...

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DexCom Alert on Stolen Glucose Monitoring Sensors

DexCom says it has identified two lots of stolen Dexcom G7 continuous glucose monitoring sensors tha...

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Medical Device Human Factors Info Submission Guidance

FDA publishes a final guidance to assist sponsors in submitting human factors information with medic...

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FDA Marks 50th Anniversary of Device Amendments

FDA marks the 50th anniversary of the 1976 Medical Device Amendments by highlighting the law’s lasti...