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FDA appoints Lisa Romano as principal deputy associate commissioner for inspections and investigations, elevating a 24-year agency veteran to one of the top leadership positions within the agency's inspection and enforcement organization.

latest-news

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

LATEST NEWS

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FDA Names Veteran Investigator as Head of Inspections/Investigations

FDA appoints Lisa Romano as principal deputy associate commissioner for inspections and investigations, elevating a 24-year agency veteran to one of the top leadership positions within the agency's inspection and enforcement organization.

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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 by CBER.

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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 undergoes a shift to one-day, streamlined inspections at low-risk facilities.

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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 institutional stewardship over professional credentials as the search continues for the next FDA commissioner.

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Animal Drugs

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medical-devices
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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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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...

medical-devices
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Panel Recommends Dominant Covid Variant for Upcoming Vaccines

An FDA advisory committee recommends updating Covid-19 vaccines for the 2026-2027 immunization season to target the currently dominant XFG variant.

FDA General

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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
Read More
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
Read More
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...

medical-devices
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Beren’s Infantile Niemann-Pick disease Drug Review Extended

FDA extends by three months its review timeline of a Beren Therapeutics NDA for adrabetadex for treating infantile-onset Niemann-Pick disease, Type C.

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Federal Register

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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 ...

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Purdue Sentencing Sets $5.3 Billion in Criminal Penalties

A federal court sentences Purdue Pharma to pay more than $5 billion in criminal penalties for its ro...

Human Drugs

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FDA Names Veteran Investigator as Head of Inspections/Investigations

FDA appoints Lisa Romano as principal deputy associate commissioner for inspections and investigatio...

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Guide on Reducing Animal Studies for Cancer Products

FDA posts a draft guidance that proposes streamlined nonclinical safety testing approaches for certa...

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ICH Q&A Document for Drug Quality Guidelines

ICH updates its long-running question-and-answer guidance tied to the ICH Q8, Q9 and Q10 pharmaceuti...

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BPI Labs Cited After FDA Inspection

FDA issues BPI Labs a Form-483 following an April inspection for potential cross-contamination risks...

Marketing

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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...

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Advertising Experts Critique FDA’s Increasing Enforcement

Pharmaceutical advertising experts react to FDA’s dramatically altered enforcement approach toward p...

Medical Devices

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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...

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FDA Updates Phillips Trilogy Ventilator Corrections

FDA issues an update on a Philips Respironics device correction involving its Trilogy Evo platfo...