Online Advisory Letter Reference # 716717 December 4, 2025 Bodynplant 96 Mowat Ave Toronto, ON M6K 3M1, CA RE: Vaginal-Uterine Cancer Bundle, Stomach Cancer Bundle, Pancreas Cancer Bundle, Liver Cancer Bundle, …
Image Caption Miracle cure! Truly amazing! Works in minutes! Guaranteed! These are just a few of the false claims made by fraudulent health care products that should serve as red flags for consumers. See below for more red flags. Español 简体中文 한국어 Việt …
Clinical Outcome Assessments (COA) Frequently Asked Questions
[1/21/2026] The U.S. Food and Drug Administration announced that it will begin accepting applications on February 1, 2026 for the PreCheck Pilot Program. This program will strengthen the domestic pharmaceutical supply chain by increasing regulatory …
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 “ …
FDA News Release New centralized program and technology upgrades dramatically enhance FDA’s ability to stop dangerous imports at U.S. borders For Immediate Release: January 21, 2026 The U.S. Food and Drug Administration today announced its initial review …
For Immediate Release: January 21, 2026 Today, the U.S. Food and Drug Administration issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food. The FDA is taking this action as a first step to improve …
Delivery Method: Via UPS and EMAIL Reference #: CBER 26-720762 Product: Biologics Recipient: Recipient Name Andreas Kogelnik, MD, PhD Recipient Title Founder & Chief Executive Officer ProDx Health 1190 O'Brien Dr Menlo Park, CA 94025 United States …
Delivery Method: Via UPS and EMAIL Reference #: CBER 26-720529 Product: Biologics Issuing Office: Center for Biologics Evaluation and Research (CBER) United States WARNING LETTER January 8, 2026 CBER 26- 720529 To Whom It May Concern: The United States …
Delivery Method: Via Email Reference #: CBER 26-720554 Product: Biologics Issuing Office: Center for Biologics Evaluation and Research (CBER) United States WARNING LETTER January 8, 2026 CBER 26- 720554 To Whom It May Concern: The United States Food and …
Delivery Method: Via UPS and EMAIL Reference #: CBER 26-720555 Product: Biologics Recipient: Recipient Name Jon Tavarez Recipient Title Founder & Chief Executive Officer Germaphobix 6950 E Adamo Dr Tampa, FL 33619 United States info@germaphobix.com …
Docket Number: FDA-2025-D-2275 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance …
Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 26-HFD-45-01-01 Product: Drugs Recipient: Recipient Name Dayan B. Goodenowe, Ph.D. Prodrome Sciences USA, LLC 27518 Via Industria Temecula, CA 92590 United States Issuing Office: Center …
Delivery Method: Via Email Reference #: 320-26-28 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Darren J. Birkelbach Recipient Title Chief Executive Officer Integrity Partners Group 1111 Industry Avenue SE Roanoke, VA 24013 United …
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 …
FDA has developed a pathway under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that allows states and Indian tribes to import certain prescription drugs from Canada to: significantly reduce the cost of these drugs to the American …
Section 804 of the Federal Food, Drug and Cosmetic Act allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs without imposing additional risk to public health and safety. FDA …
This quality assurance (QA) tool is designed to assist section 804 importation program (SIP) sponsors prepare proposals that fully comply with the requirements under the final rule. The QA tool organizes overall requirements in a structured format by …
FDA has issued policies and taken actions to implement section 804 of the Federal Food, Drug and Cosmetic Act, which allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs without …
The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
06 days 21:25:35
