U.S. Food and Drug Administration Press Releases - EIN Presswire

Published on August 22, 2024 - 23:11 GMT

Meetings for Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy (BT) Designated Products

Breakthrough Therapy (BT) Designation and Regenerative Medicine Advanced Therapy (RMAT) Designation are two of the expedited programs that may apply to cellular and gene therapy products that are intended to treat, modify, reverse, or cure a serious …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 22, 2024 - 17:47 GMT

Drug Trials Snapshots: PIASKY

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 22, 2024 - 14:34 GMT

Authentik Fudge Recalls Fudge with Nuts Because of Potential Mold Growth

Summary Company Announcement Date: August 21, 2024 FDA Publish Date: August 22, 2024 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential mold growth contamination Company Name: Authentik Fudge …

Distribution channels: Food & Beverage Industry

Published on August 22, 2024 - 13:43 GMT

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Polymyxin B for Injection USP, 500,000 Unit per Vial, Due to the ...

COMPANY ANNOUNCEMENT This recall has been completed and FDA has terminated this recall. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 21, 2024 - 20:41 GMT

Unilever U.S. Issues Allergy Alert on Undeclared Milk in Popsicle Jolly Rancher SingleServe Frozen Confection Pops

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry

Published on August 21, 2024 - 19:47 GMT

Boulla LLC Issues Voluntary Nationwide Recall of Boom Max Capsules Due to the Potential Presence of Undeclared Sildenafil

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

Distribution channels: Food & Beverage Industry

Published on August 21, 2024 - 18:55 GMT

Veata LLC Issues Voluntary Nationwide Recall of Endurance Pro Capsules Due to the Potential Presence of Undeclared Sildenafil

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

Distribution channels: Food & Beverage Industry

Published on August 21, 2024 - 15:48 GMT

Electronic Regulatory Submission and Review

This page provides information about the electronic submission of regulatory information to the Center and the review of it by CDER staff. The Electronic Common Technical Document (eCTD) is the standard, accepted electronic format for the following …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 21, 2024 - 13:52 GMT

Global IDMP Implementation - Getting Closer to the Goal - 10/16/2024

On This Page Date: October 16, 2024 Time: 1:00 PM - 2:30 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT (Hosted by CDER SBIA) Identification of Medicinal Products (IDMP) offers a global framework for the unique identification …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 20, 2024 - 20:33 GMT

Vaccines and Related Biological Products Advisory Committee September 20, 2024 Meeting Announcement - 09/20/2024

Date: September 20, 2024 Time: 8:30 AM - 5:00 PM ET What is an advisory committee? Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 20, 2024 - 19:37 GMT

FDA Roundup: August 20, 2024

For Immediate Release: August 20, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA approved Lazcluze (lazertinib) in combination with amivantamab for the first-line …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 20, 2024 - 16:22 GMT

Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of ...

In 2017, FDA’s Center for Drug Evaluation and Research (CDER) embarked on an initiative to modernize the New Drugs Regulatory Program. For more information on this initiative, please visit Modernizing FDA’s New Drugs Regulatory Program. One critical …

Distribution channels: Healthcare & Pharmaceuticals Industry