FDA Webview
X
wifi-social twitter-social
search
latest-news
Human Drugs

Redact CRLs for Unapproved Applications: Petition

An unidentified major drug company calls on FDA to establish a process for redacting complete response letters for unapproved applications before they are released to protect confidential commercial information.

Continue Reading
latest-news
Human Drugs

Senate Democrats Target Trump Drug Pricing Deals

Senate Democrats, led by Ron Wyden (D-OR), introduce legislation aimed at forcing the Trump administration to disclose the terms of pricing agreements it has struck with major pharmaceutical companies.

Continue Reading
fda-generl-home
Human Drugs

FDA Expands Approval of Sanofi’s Tzield to Younger Children

fda-generl-home
Human Drugs

FDA extends review for Sanofi’s subcutaneous Sarclisa

fda-generl-home
Medical Devices

FDA Denies Petition to Withdraw Approval of VenaSeal

fda-generl-home
Human Drugs

Warning Letter to Firm Over Weight-loss/Diabetes Drugs

LATEST NEWS

View All
motusgi
Redact CRLs for Unapproved Applications: Petition

An unidentified major drug company calls on FDA to establish a process for redacting complete response letters for unapproved applications before they are released to protect confidential commercial information.

motusgi
Senate Democrats Target Trump Drug Pricing Deals

Senate Democrats, led by Ron Wyden (D-OR), introduce legislation aimed at forcing the Trump administration to disclose the terms of pricing agreements it has struck with major pharmaceutical companies.

motusgi
Warning Letter to Firm Over Weight-loss/Diabetes Drugs

FDA issues a Warning Letter to New Life Pharma citing serious manufacturing and regulatory violations tied to the company’s production of injectable weight-loss and diabetes drugs.

motusgi
4 Ways to Better Use CRISPR-Edited Therapies: Article

Researchers describe FDA and congressional actions that will improve the ability of the new plausible mechanism pathway to lead to the development of personalized gene-edited therapies for rare diseases.

Categories

Top News

newsletter-first

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Animal Drugs

View All
medical-devices
Read More
Lilly to Seek FDA Approval for Foundayo in Diabetes

Eli Lilly says it will seek expanded FDA approval by the end of the quarter for its obesity drug Foundayo (orforglipron) as a treatment for diabetes, ...

medical-devices
Read More
2 CDER Postmarketing MAPPS Out

CDER issues two revised Manuals of Policies and Procedures relating to developing and communicating postmarketing requirements and commitments.

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.

Biologics

View All
medical-devices
Read More
FDA Accepts Roche sBLA for Gazyva in Lupus

FDA accepts a Roche supplemental BLA that seeks to expand use of Gazyva to treat Systemic Lupus Erythematosus.

medical-devices
Read More
Eye Doctor Emerges as Contender for CBER Head

FDA is reportedly considering ophthalmologist and biotech executive Houman Hemmati as CBER’s next director.

medical-devices
Read More
FDA rejects Replimune Melanoma Therapy Again

FDA issues Replimune another complete response letter, declining to approve its BLA for vusolimogene oderparepvec in combination with nivolumab for ad...

medical-devices
Read More
Organogenesis Advances ReNu Toward FDA Filing After Key Meeting

Organogenesis says it has reached agreement with FDA that clears the way for a rolling BLA submission for its knee osteoarthritis product ReNu.

FDA General

View All
medical-devices
Read More
FDA Approves Merck’s Idvynso for Treating HIV

FDA approves Merck’s Idvynso, a once-daily, single-tablet regimen for adults with HIV-1 who are already virologically suppressed.

medical-devices
Read More
Outlook Therapeutics Completes FDA Dispute Meeting on Lytenava

Outlook Therapeutics completes a formal dispute resolution meeting with FDA as part of the company’s push to revive its approval prospects for ONS-501...

medical-devices
Read More
FDA Lays Out Next Phase of Plan to Reduce Animal Testing

FDA outlines expanded efforts to reduce animal testing in drug development after reporting significant first-year progress under its roadmap to modern...

medical-devices
Read More
Collins Presses for Faster Generic Competition at Hearing

U.S. Sen. Susan Collins (R-ME) uses a Senate hearing 4/16 to spotlight barriers to lower-cost drugs, pressing an expert witness on delays in bringing ...

newsletter-second

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Federal Register

View All
motusgi
Read More
Padcev-Keytruda Combo for Broader Bladder Cancer

FDA accepts for priority review a Pfizer and Astellas Pharma supplemental BLA for Padcev (enfortuma...

motusgi
Read More
FDA Streamlined Compliance Policy for Certain Respirators

FDA issues a draft guidance outlining a proposed compliance policy that could ease certain premarket...

motusgi
Read More
Phillips Ventilator Correction is Class 1 Recall

FDA classifies a correction involving certain ventilators manufactured by Philips as a Class I recal...

motusgi
Read More
FDA Updates Compliance Program for Biologic Drug Manufacturers

FDA issues an updated compliance program that standardizes how inspectors evaluate manufacturing fac...

Human Drugs

View All
motusgi
Read More
Redact CRLs for Unapproved Applications: Petition

An unidentified major drug company calls on FDA to establish a process for redacting complete respon...

motusgi
Read More
Senate Democrats Target Trump Drug Pricing Deals

Senate Democrats, led by Ron Wyden (D-OR), introduce legislation aimed at forcing the Trump administ...

motusgi
Read More
Warning Letter to Firm Over Weight-loss/Diabetes Drugs

FDA issues a Warning Letter to New Life Pharma citing serious manufacturing and regulatory violation...

motusgi
Read More
4 Ways to Better Use CRISPR-Edited Therapies: Article

Researchers describe FDA and congressional actions that will improve the ability of the new plausibl...

Marketing

View All
motusgi
Read More
Will the Push for DTC Pre-Review Grow?

Two Hyman, Phelps & McNamara attorneys describe the impacts on industry if FDA responds to a congres...

motusgi
Read More
Alymsys Patient Brochure False or Misleading: FDA

The CDER Office of Prescription Drug Promotion says an Amneal patient brochure for its Avastin biosi...

motusgi
Read More
Lucemyra Web Site Home Page False or Misleading: FDA

FDA cautions BioCorRx about false and misleading information on the Web site home page for its Lucem...

motusgi
Read More
Modernize DTC Ads with QR Code: WLF

A Washington Legal Foundation background document suggests that Congress change direct-to-consumer d...

Medical Devices

View All
motusgi
Read More
FDA Denies Petition to Withdraw Approval of VenaSeal

FDA denies a citizen petition seeking to withdraw approval of Covidien’s VenaSeal vein-closure syste...

motusgi
Read More
Philips Wins Clearance for AI-powered Spectral CT System

FDA clears a Philips 510(k) for its new Spectral CT Verida system, which the company describes as th...

motusgi
Read More
AdvaMed Recommendations for Class 2 Notification Exemption

AdvaMed says it supports FDA efforts to expand exemptions from premarket notification for some Class...

motusgi
Read More
Town Hall Discusses QMSR Basics and Answers Questions

An FDA town hall gives a detailed explanation of the new medical device Quality Management System Re...