FDA Webview
X
latest-news

It appears more likely that the federal government, including FDA, will face a 10/1 shutdown due to a Congressional impasse to approve an appropriations bill for fiscal year 2024.

latest-news

FDA releases a two-item Form FDA-483 citing GMP issues documented at Novo Nordisk’s Clayton, NC facility during a 7/6-13 inspection.

LATEST NEWS

View All
motusgi
Government, FDA Shutdown Appearing More Likely

It appears more likely that the federal government, including FDA, will face a 10/1 shutdown due to a Congressional impasse to approve an appropriations bill for fiscal year 2024.

motusgi
FDA Releases Novo Nordisk FDA-483

FDA releases a two-item Form FDA-483 citing GMP issues documented at Novo Nordisk’s Clayton, NC facility during a 7/6-13 inspection.

motusgi
Legislation Introduced to Improve Device Recalls

U.S. Senator Dick Durbin (D-IL) and Representative Jan Schakowsky (D-IL) introduce bicameral legislation to improve the medical device recall process.

motusgi
Panel Votes Down Intarcia Diabetes Implant

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee votes 19 to 0 against approving Intarcia Therapeutics’ implantable ITCA 650 (exenatide in DUROS device), indicated for improving glycemic control in adults with Type 2 diabetes.

newsletter-first

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Animal Drugs

View All
medical-devices
Read More
FDA Floats Food-Animal Antibiotic Use Group

FDA solicits comments on a report outlining a structure for a public/private partnership to establish and operate a repository of antimicrobial use da...

medical-devices
Read More
CVM Guide on Soluble Powder Bioequivalence

FDA publishes a CVM guidance entitled “#171 Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Co...

medical-devices
Read More
FDA/EU MRA Now Includes Animal Inspections

FDA and the European Union agree to expand the scope of the U.S.-EU mutual recognition agreement to include inspections of veterinary pharmaceuticals.

medical-devices
Read More
Complete Response on Bladder Cancer BLA

FDA sends ImmunityBio a complete response letter on its BLA for Anktiva (N-803) in combination with Bacillus Calmette-Guérin (BCG) for treating certai...

Biologics

View All
medical-devices
Read More
Taysha Discontinues Gene Therapy Program

Taysha Gene Therapies says it is discontinuing the development of its gene therapy TSHA-120 program as a treatment for giant axonal neuropathy after r...

medical-devices
Read More
Atara Bio Plans BLA for Tabelecleucel

Atara Biotherapeutics says it expects to file by 7/2024 a BLA for tabelecleucel, an allogeneic, Epstein-Barr virus-specific T-cell immunotherapy.

medical-devices
Read More
English Doctor Attacks FDA/CDC Covid Vaccine Data

A retired English doctor with almost 3 million YouTube subscribers scorns CDC and FDA data supporting mass vaccination of all Americans over six month...

medical-devices
Read More
FDA Extends BLA Review of Melanoma Therapy

FDA extends by 90 days its review of an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating pa...

FDA General

View All
medical-devices
Read More
Government, FDA Shutdown Appearing More Likely

It appears more likely that the federal government, including FDA, will face a 10/1 shutdown due to a Congressional impasse to approve an appropriatio...

medical-devices
Read More
Keep FDA Logo Out of Materials: Agency

FDA reminds industry and others about its policy on using the “FDA” name and logo in any materials without being specifically authorized by the agency...

medical-devices
Read More
Inmar Recalls Products Due to Rodent Infestation

Inmar Supply Chain Solutions recalls FDA-regulated products (over-the-counter (OTC) human or animal drugs, OTC medical devices, dietary supplements, f...

medical-devices
Read More
Drug Shortages are National Security Risk: Califf

FDA commissioner Robert Califf tells an Alliance for a Stronger FDA webinar that ongoing drug shortages are a huge national security risk and better i...

newsletter-second

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Federal Register

View All
motusgi
Read More
PDUFA Formal Meetings Guidance

Federal Register notice: FDA makes available a draft guidance entitled “Formal Meetings Between the ...

motusgi
Read More
Guide on Inspection Alternative Tools

Federal Register notice: FDA makes available a draft guidance entitled “Alternative Tools: Assessing...

motusgi
Read More
Comments Reopened on Opioid Disposal

Federal Register notice: FDA reopens the comment period for the 4/4 notice entitled “In-Home Disposa...

motusgi
Read More
Emergency Clinical Trial Conduct Guidance

Federal Register notice: FDA makes available a final guidance entitled “Considerations for the Condu...

Human Drugs

View All
motusgi
Read More
FDA Releases Novo Nordisk FDA-483

FDA releases a two-item Form FDA-483 citing GMP issues documented at Novo Nordisk’s Clayton, NC faci...

motusgi
Read More
Panel Votes Down Intarcia Diabetes Implant

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee votes 19 to 0 against approving Intarcia...

motusgi
Read More
Senators Urge FDA to Strengthen Opioid Studies

Senators Edward Markey (D-MA) and Joe Manchin (D-WV) call on FDA to curb the use of enriched enrollm...

motusgi
Read More
FDA OKs Jardiance in Chronic Kidney Disease

FDA approves Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) 10 mg tablets for treati...

Marketing

View All
motusgi
Read More
OPDP Cites Exeltis’ Promos on Social Media

CDER Office of Prescription Drug Promotion cites Exeltis USA for making false or misleading claims i...

motusgi
Read More
Comments on OPDP Quantitative Claims Research

Two stakeholders raise questions about proposed Office of Prescription Drug Promotion research into ...

motusgi
Read More
DTC Efficacy and Risk Information Guidance

FDA publishes a guidance on how to present more consumer-friendly efficacy and risk information in d...

motusgi
Read More
More Groups, Experts Back KEI Ad Music Petition

Three stakeholder groups and seven individuals call for FDA to promptly approve a Knowledge Ecology ...

Medical Devices

View All
motusgi
Read More
Legislation Introduced to Improve Device Recalls

U.S. Senator Dick Durbin (D-IL) and Representative Jan Schakowsky (D-IL) introduce bicameral legisla...

motusgi
Read More
Guidance on ISO-10993-1 Explained

Three Hogan Lovells attorneys analyze a recent FDA guidance on using the ISO 10993-1 international s...

motusgi
Read More
MicroVention Transradial Access Catheter Cleared

FDA grants Terumo’s MicroVention unit 510(k) clearance for its SOFIA EX 5F 115 cm intracranial suppo...

motusgi
Read More
FDA Recalls Saline Solution

Medline Industries recalls its Hudson RCI Addipak unit dose vial, 0.9% full normal saline solution (...