On This Page Date: February 5, 2026 Time: 12:00 p.m. - 1:00 p.m. ET To Attend For technical assistance please contact: Rakesh.Raghuwanshi@fda.hhs.gov Speakers Elizabeth Petro, PhD Supervisory Chemist, Branch Chief Megumi Yamamoto, MS Chemist, Project …
Full drug marketing application submissions under 21 CFR subpart 314.50 and 314.54 should be directed to: Center for Drug Evaluation and Research Food and Drug Administration Document and Records Section 5901-B Ammendale Rd Beltsville, Md. 20705-1266 …
Analgesics Drugs that relieve pain. There are two main types: non-narcotic analgesics for mild pain, and narcotic analgesics for severe pain. Antacids Drugs that relieve indigestion and heartburn by neutralizing stomach acid. Antianxiety Drugs Drugs that …
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.
Once an IND application is in effect, the sponsor of the application may amend the application as needed to ensure that the clinical investigations are conducted according to protocols included in the IND application. Sponsors are expected to submit …
Sponsors of IND applications may obtain advice and guidance from FDA at any stage of IND development. A sponsor may consult with the Agency before formal submission of an IND application and send a pre-IND meeting request to an appropriate Review Division …
Sponsors of IND applications are responsible for sending periodic updates and reports related to their applications to FDA. All submissions with IND application amendments or reports should include Form 1571 (PDF - 830KB) sent along with the respective …
Investigator’s Responsibilities This page provides the key points that investigators should consider in order to understand their responsibilities regarding an IND application. For full description of investigator’s and sponsor’s responsibilities including …
Not all investigator-initiated clinical investigations require an Investigational New Drug (IND) application. Before contacting FDA or submitting an IND for an investigator-initiated clinical investigation, investigators should review the exemption …
Summary Company Announcement Date: January 28, 2026 FDA Publish Date: January 29, 2026 Product Type: Animal & Veterinary Reason for Announcement: Recall Reason Description Micorbial Contamination Company Name: Neogen Corporation Brand Name: Product …
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 …
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: Marty Makary, M.D., M.P.H., Commissioner of Food and Drugs 2026 is a special year for the U.S. Food and Drug Administration. It marks our 120th year of service to this nation. In honor of this occasion, and to help the public better understand …
On January 27, 2026, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple …
Delivery Method: Via Email Reference #: 320-26-37 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Soo Nam Tan Recipient Title Group Executive Chairman Fulijaya Manufacturing SDN. BHD. No. 30, Loring Makmur 13/1 Taman Makmur Industrial …
Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 26-HFD-45-01-02 Product: Drugs Recipient: Recipient Name Bruce S. Gillis, M.D., MPH Center For Immunology Science, LLC 2109 Granville Avenue Los Angeles, CA 90025-6105 United States …
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 This Page Date: June 2 - 4, 2026 Time: 8:30 a.m. - 5:15 p.m. ET Location: Event Location Library and Archives Canada, Ottawa and Virtual 395 Wellington St. Ottawa ON K1A 0N4 Canada Image Register This symposium will highlight current and emerging topics …
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 …
02 days 06:52:05
