For Immediate Release: April 13, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Given the anticipated increase in demand for chloroquine phosphate and …
On August 6, 2025, the Food and Drug Administration granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals, Inc.), a protease activator, for adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an …
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 …
Summary Company Announcement Date: June 06, 2025 FDA Publish Date: June 06, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Salmonella Company Name: August Egg Company Brand Name: Brand Name(s) Product Description …
Over-the-counter (OTC) drugs are developed under the OTC Monograph Process or through the New Drug Application (NDA) Process.
Docket Number: FDA-2023-D-0093 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “M13B Bioequivalence for …
FDA and state pharmaceutical regulators meet regularly to advance their collective efforts to improve the quality of compounded drugs and protect consumers from unsafe compounded drugs. In the most recent Intergovernmental Working Meeting on Drug …
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 …
Delivery Method: Via Electronic Mail - Delivery and Read Receipt Requested Reference #: FEI 3010165392 Product: Drugs Recipient: Recipient Name Mr. Alok K. Garg Recipient Title Managing Director Medgel Private Limited Plot No. 19-20, Special Economic Zone …
Docket Number: FDA-2025-D-0507 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Replacing Color Additives …
Submit Comments by 07/28/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online …
On This Page Date: May 29, 2025 Time: 12:00 p.m. - 1:00 p.m. ET Speaker Jayaleka J. Amarasinghe, Ph.D. Microbiologist Winchester Engineering and Analytical Center (WEAC) Office of Specialty Laboratories & Enforcement Support (OSLES) Office of Chief …
1 Columbia University Medical Center New York, New York 2 Brigham and Women's Hospital Boston, Massachusetts 8 University of Kansas Medical Center Kansas City, Kansas 10 University of Pennsylvania Philadelphia, Pennsylvania 11 University of Virginia …
On This Page Date: July 11, 2025 Time: 9:00 a.m. - 2:00 p.m. ET The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for …
Delivery Method: Via Email Product: Drugs Recipient: Shenzhen Hengkaifeng Commerce and Trade Co., Ltd 3A-18, Wansheng Baihuo, Wanzhong City, Xinniu Community, Minzhi Sub-District Longhua Qu Shenzhen Shi Guangdong Sheng, 518000 China zzkk15944@gmail.com …
Delivery Method: VIA UPS Reference #: 320-25-72 Product: Drugs Recipient: Recipient Name Mr. Atul B. Mehta Recipient Title President, Co-Chairman, and Co-Founder AACE Pharmaceuticals, Inc. 15 Gardner Road Fairfield, NJ 07004 United States Issuing Office: …
AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Dermatology ISSUE: The FDA is warning that patients stopping the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience rare but severe …
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 …
Summary Company Announcement Date: May 23, 2025 FDA Publish Date: May 23, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Salmonella Company Name: JFE Franchising Inc. Brand Name: Brand Name(s) …
