Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Shirly Gutshtat, CEO Recipient Title Keren Elisar, Founder & President K & Care Organics Simtat Hadayagim 2 St Mikhmoret 4029700 Israel info@kcare.co.il Issuing Office: Center for …
Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Dr. Harry Fallick Recipient Title Founder & CEO Fallien Cosmeceuticals Ltd. dba Fallene Ltd. 2541 General Armistead Ave Norristown, PA 19403 United States info@tizoskin.com Issuing …
Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Lisa Sequino Supergoop! 200 East Grayson Suite #110 San Antonio, TX 78215 United States hello@supergoop.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States …
Delivery Method: VIA UPS Reference #: 320-25-90 Product: Drugs Recipient: Recipient Name Mr. Neal Flowers Recipient Title President Gussyup LLC dba Private Label Grooming 7360 Eastgate Rd, Suite 135 Henderson, NV 89011-4091 United States Issuing Office: …
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 …
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 …
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 …
On October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and …
Safety Pharmacology General safety pharmacology testing Safety pharmacology endpoints may be incorporated into general toxicity studies in order to reduce animal use. This practice is routine for biologics. May include non-animal methods. May be based on …
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 …
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 …
On This Page Date: September 11, 2025 Time: 12:30 p.m. - 3:30 p.m. ET FDA, in partnership with the Reagan-Udall Foundation, will host the sixth Online Controlled Substances Summit. Illegal online sales of controlled substances pose significant health risks …
Docket Number: FDA-2019-D-2102 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance describes the Agency’s recommendations on the design and evaluation of comparative …
For Immediate Release: August 08, 2025 U.S. Food and Drug Administration Commissioner Dr. Marty Makary, M.D., M.P.H., and U.S. Secretary of Agriculture Brooke L. Rollins this week announced plans to support American citrus growers and cut bureaucratic …
On August 8, 2025, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer …
For Immediate Release: August 08, 2025 Statement From: Martin A Makary, M.D., M.P.H. Commissioner of Food and Drugs - Food and Drug Administration I am pleased to announce that the nationwide shortage of sodium chloride 0.9% injection products, a form of …
Note: The following information is to be used by physicians who would like to request an Emergency IND for an antiviral product regulated by the Center for Drug Evaluation and Research (CDER)/Division of Antivirals (DAV). DAV regulates products that are …
Online Advisory Letter Reference # 703111 June 17, 2025 Ananeoo Wellness LLC 1785 South Patrick Dr. Indian Harbour Beach, FL 32937 CustomerCare@ananeoo.com RE: Ananeoo Cellular Nutrition & Detoxification Dear Ananeoo Wellness LLC: This letter …
FDA News Release Labeling change will affect all opioid pain medications and support more informed decision-making For Immediate Release: July 31, 2025 The U.S. Food and Drug Administration is requiring safety labeling changes to all opioid pain …
Using its authority under Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act, FDA required extended-release/long-acting (ER/LA) opioid analgesic (OA) new drug application holders to conduct epidemiologic studies to 1) quantify the serious risks …
