FDA Webview
X
latest-news

FDA warns Eatontown, NJ-based Avertix Medical about Quality System, Medical Device Reporting, and Correction and Removal violations in its production of a coronary syndrome event detector.

latest-news

FDA warns India’s Patcos Cosmetics that it is marketing adulterated over-the-counter drug products that have significant violations of CGMPs.

LATEST NEWS

View All
motusgi
Multiple Avertix Medical Violations Cited

FDA warns Eatontown, NJ-based Avertix Medical about Quality System, Medical Device Reporting, and Correction and Removal violations in its production of a coronary syndrome event detector.

motusgi
India’s Patcos Markets Insanitary OTC Drugs with CGMP Issues: FDA

FDA warns India’s Patcos Cosmetics that it is marketing adulterated over-the-counter drug products that have significant violations of CGMPs.

motusgi
Guide Aims to Expand Non-Animal Methods in Drug Development

FDA issues a draft guidance encouraging drug developers to adopt new approach methodologies as part of a broader effort to reduce reliance on animal testing and improve the prediction of human drug safety.

motusgi
Oralabs Cited for CGMP Violations

FDA warns Parker, CO-based Oralabs about CGMP violations in its work as a contract drug manufacturer.

newsletter-first

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Animal Drugs

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

View All
medical-devices
Read More
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...

medical-devices
Read More
GSK’s Arexvy RSV Vaccine for High-Risk Adults Ages 18–49

FDA expands the approved use of GSK’s Arexvy, a respiratory syncytial virus accine that now includes the in adults aged 18 to 49 who are at increased ...

medical-devices
Read More
FDA Panel Backs Trivalent Influenza Vaccine for 2027 Season

FDA’s Vaccines and Related Biological Products Advisory Committee votes to recommend that seasonal influenza vaccines for the 2026–2027 U.S. season us...

medical-devices
Read More
FDA Flags Safety Reporting Lapses at U.K. Clinical Trial Site

FDA cites a U.K.-based clinical research center for failing to promptly report adverse events and for potential falsification of study records during ...

FDA General

View All
medical-devices
Read More
Senators Demand HHS Reverse Autism-Related Web Site Changes

A group of U.S. senators is pressing HHS to reverse recent changes to FDA and other federal health Web sites, warning that altered guidance on vaccine...

medical-devices
Read More
FDA Updates Internal Procedures for Handling Supplements

FDA updates an internal policy document outlining how CBER staff process supplements to approved drug and biologic applications.

medical-devices
Read More
FDA Warning Letters Surge in FY2025, Report Finds

A regulatory consulting firm's report finds that FDA sharply increased enforcement activity against drugmakers and distributors in fiscal year 2025, i...

medical-devices
Read More
FDA Opens New, Searchable Adverse Event Platform

FDA launches its new Adverse Event Monitoring System to ultimately house all adverse events reported on FDA-regulated products on one searchable platf...

newsletter-second

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Federal Register

View All
motusgi
Read More
PDUFA Public Meeting for User Fee Reauthorization

Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for...

motusgi
Read More
Generic Drug Fee Program Reauthorization Meeting

Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug ...

motusgi
Read More
FDA Withdraws and Reissues 2 Guidances

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissui...

motusgi
Read More
CDER Continues Quality Management Program

Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second ye...

Human Drugs

View All
motusgi
Read More
India’s Patcos Markets Insanitary OTC Drugs with CGMP Issues: FDA

FDA warns India’s Patcos Cosmetics that it is marketing adulterated over-the-counter drug products t...

motusgi
Read More
Guide Aims to Expand Non-Animal Methods in Drug Development

FDA issues a draft guidance encouraging drug developers to adopt new approach methodologies as part ...

motusgi
Read More
Oralabs Cited for CGMP Violations

FDA warns Parker, CO-based Oralabs about CGMP violations in its work as a contract drug manufacturer...

motusgi
Read More
API Deviations Seen in Flowchem Pharma Inspection

FDA warns India’s Flowchem Pharma about significant CGMP deviations in its production of active phar...

Marketing

View All
motusgi
Read More
Hims & Hers Super Bowl Ad Hit

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

motusgi
Read More
FDA DTC Ad Crackdown Raises Legal Issues: Attorneys

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

motusgi
Read More
Neffy Broadcast Ad ‘False or Misleading’: OPDP

An FDA Untitled Letter cautions ARS Pharmaceutical about false or misleading claims for its Neffy na...

motusgi
Read More
Cobenfy Ad Letter Signals Tight Limits on DTC Claims: Attorneys

A December FDA violation letter targeting a schizophrenia drug advertisement from Bristol Myers Sq...

Medical Devices

View All
motusgi
Read More
Multiple Avertix Medical Violations Cited

FDA warns Eatontown, NJ-based Avertix Medical about Quality System, Medical Device Reporting, and Co...

motusgi
Read More
Integra Neurosurgical Kits Recalled Over Corrosion Risk

Integra LifeSciences recalls certain neurosurgical monitoring kits, citing potential safety risks li...

motusgi
Read More
Insulet Device Correction for Certain Omnipod 5 Insulin Pods

Insulet initiates a Class 1 device correction for certain lots of its Omnipod 5 Automated Insulin De...

motusgi
Read More
FDA OKs J&J’s Tecnis PureSee Lens for Cataract Surgery

FDA approves Johnson & Johnson’s Tecnis PureSee Intraocular Lens, a new extended depth-of-focus lens...