FDA will host Rare Disease Day, a virtual public meeting, on Monday, February 23, 2026, in global observance of Rare Disease Week. The theme is: “Moving Forward. Looking Ahead. An Event for Patients.” Learn more and register here.
Docket Number: FDA-2026-D-0207 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Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance …
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 …
FDA News Release Agency also grants two petitions to expand alternative food color options For Immediate Release: February 05, 2026 Today, the U.S. Food and Drug Administration took additional steps to support the transition of our nation’s food supply …
What We Do CDER SBIA is often the first stop for a small pharmaceutical business trying to contact the Agency. Our goal is to help small pharmaceutical business and industry navigate the wealth of information that FDA offers, and to assist in understanding …
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 “ …
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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 “ …
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-2021-D-1158 Issued by: Guidance Issuing Office Center for Devices and Radiological Health Center for Biologics Evaluation and Research This document provides FDA’s recommendations to industry regarding cybersecurity device design, …
Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 320-26-39 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Eric Jon Gripentrog Recipient Title Chief Executive Officer HTO Nevada, Inc. dba Kirkman 6400 …
Delivery Method: VIA Electronic Mail Reference #: 320-26-40 Product: Drugs Recipient: Recipient Name Dr. Vetukuri Venkata Naga Kali Vara Prasada Raju Recipient Title Managing Director & Chief Executive Officer Cohance Lifesciences Limited 202, 2nd …
Feb. 8, 2018 Media Inquiries Sandy Walsh 301-796-4669 “Since becoming Commissioner I’ve made it my goal to improve patient access to affordable drugs. No patient should be priced out of critical medicine. It’s a public health concern if patients can’t …
September 20, 2019 Media Inquiries Sandy Walsh 301-796-4669 “Abuse of loperamide continues in the United States, and taking higher than recommended doses can cause serious heart problems that can lead to death,” said Acting FDA Commissioner Ned …
STN: 125832 Proper Name: zopapogene imadenovec-drba Tradename: PAPZIMEOS Manufacturer: Precigen, Inc. Indication: For the treatment of adults with recurrent respiratory papillomatosis. Product Information Supporting Documents Content current as of: 03/ …
FDA regulates human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient. These are referred to as human cells, tissue, and cellular and tissue-based products, or HCT/Ps, and are regulated under Title 21 …
For people 60 years of age and older, the studies for Zostavax enrolled approximately 38,000 people throughout the United States; approximately half received Zostavax and half received placebo. Study participants were followed on average for about three …
COVID-19 vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to generate the needed non-clinical, clinical, and manufacturing data. FDA will undertake a comprehensive evaluation of this information …
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 “ …
Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: FEI 3015892095 Product: Drugs Recipient: Recipient Name Mr. Matteo Scarpis Eurosirel S.P.A Viale Europa 30 20047 Cusago MI Italy matteo.scarpis@eurosirel.it Issuing Office: Center …
