FDA Webview
X
latest-news

FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.

latest-news

FDA warns Mexico’s Laboratorios Jaloma about CGMP violations in its production of finished drugs.

LATEST NEWS

View All
motusgi
Repeat Medline CGMP Violations Cited

FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.

motusgi
CGMP Violations at Laboratorios Jaloma

FDA warns Mexico’s Laboratorios Jaloma about CGMP violations in its production of finished drugs.

motusgi
Manufacturer Economic Info Communications Q&A Guidance

FDA publishes a draft question-and-answer guidance on manufacturer communication of health care economic information to payors.

motusgi
ICH Finalizes Guide on Model-Informed Drug Development

FDA makes available an International Council for Harmonization guidance that establishes a global framework for using computational modeling and simulation in drug development.

newsletter-first

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Animal Drugs

View All
medical-devices
Read More
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
Read More
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
Read More
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
Read More
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

View All
medical-devices
Read More
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
Read More
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
Read More
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
Read More
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

View All
medical-devices
Read More
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
Read More
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.

newsletter-second

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Federal Register

View All
motusgi
Read More
FDA Delays Review Action on Alzheimer’s Drug

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

motusgi
Read More
Alnylam Pharma’s Web Promo is Misleading: FDA

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

motusgi
Read More
PhRMA Urges Changes to FDA’s ‘Plausible Mechanism’ Guidance

PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that ...

motusgi
Read More
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

View All
motusgi
Read More
Repeat Medline CGMP Violations Cited

FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, fa...

motusgi
Read More
CGMP Violations at Laboratorios Jaloma

FDA warns Mexico’s Laboratorios Jaloma about CGMP violations in its production of finished drugs.

motusgi
Read More
ICH Finalizes Guide on Model-Informed Drug Development

FDA makes available an International Council for Harmonization guidance that establishes a globa...

motusgi
Read More
Guide on Using Prior Knowledge for Genome Editing Gene Therapies

FDA posts a draft guidance outlining how developers of genome-editing gene therapies can leverage ex...

Marketing

View All
motusgi
Read More
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...

motusgi
Read More
DTC Crackdown Unfazed at Post-Makary FDA: Expert

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

motusgi
Read More
Brukinsa TV Ad ‘False or Misleading’: OPDP

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

motusgi
Read More
Advertising Experts Critique FDA’s Increasing Enforcement

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

Medical Devices

View All
motusgi
Read More
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...

motusgi
Read More
DexCom Alert on Stolen Glucose Monitoring Sensors

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

motusgi
Read More
Medical Device Human Factors Info Submission Guidance

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

motusgi
Read More
FDA Marks 50th Anniversary of Device Amendments

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