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 …
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 …
Image By: ShaAvhrée Buckman-Garner, M.D., Ph.D., Director of Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), and Mary Thanh Hai, M.D., Acting Director of Office of New Drugs, CDER The U.S. Food and Drug Administration …
Spotlight Events & Announcements Get Started with Your Submission The Innovative Science and Technology Approaches for New Drugs (ISTAND) Program accepts submissions for qualification of types of drug development tools (DDTs) that are out of scope for …
Submission Process The 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any …
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 …
Docket Number: FDA-2018-D-1873 Issued by: Guidance Issuing Office Center for Devices and Radiological Health Center for Biologics Evaluation and Research This final guidance updates the previous version of the guidance, titled “Medical Device User Fee …
STN: BL 125070 Proper Name: Rh0(D) Immune Globulin Intravenous (Human) Tradename: RHOPHYLAC Manufacturer: CSL Behring AG, License #1766 Indication: RHOPHYLAC is Rh(D) Immune Globulin Intravenous (Human) indicated for: Suppression of Rhesus (Rh) …
Field Science - Laboratory Manual The Laboratory Manual of Quality Policies is a reference manual for laboratory personnel and supporting units. This manual has been prepared to meet the requirements for the laboratories’ accreditation to the International …
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