STN: BL 103914 Proper Name: Influenza Virus Vaccine Tradename: Fluzone and Fluzone High-Dose Manufacturer: Sanofi Pasteur, Inc Indication: Fluzone is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype …
Alpha-1-antitrypsin deficiency (pulmonary disease or lung disease) Patients with congenital alpha-1 antitrypsin deficiency Plasma alpha-1 proteinase inhibitor Traditional Alpha-1 protease inhibitor augmentation Acid sphingomyelinase deficiency non–central …
Docket Number: FDA-2007-D-0434 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This document provides guidance to industry on postmarketing serious adverse event reporting for nonprescription (over-the-counter (OTC)) human drug …
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 “ …
Docket Number: FDA-2013-D-0636 Issued by: Guidance Issuing Office Center for Devices and Radiological Health FDA published a final rule establishing a unique device identification system (UDI Rule) on September 24, 2013. It requires the labels and device …
On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.
Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Curtis Miller Prime Vitality, Inc. dba Prime Peptides 735 State St., Ste 422 Santa Barbara, CA 93101 United States info@primepeptides.co Issuing Office: Center for Drug Evaluation and …
Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices WARNING LETTER December 10, 2024 Dear Swisschems: This letter is to advise you that the United States Food and …
Delivery Method: Via Email Product: Drugs WARNING LETTER 694688 December 10, 2024 Dear Sima Sistani: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.veronvy. …
Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-21 Product: Drugs Recipient: Recipient Name Mr. Vinod Ranka Recipient Title Managing Director Micro Orgo Chem 57, C-1B, LIC sector, GIDC Vapi 396195 Gujarat India info@mocind.com Issuing …
Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Andrew Pierce Xcel Research LLC 1309 Coffeen Ave., Suite 12238 Sheridan, WY 82801 United States Support@XcelPeptides.com Issuing Office: Center for Drug Evaluation and Research (CDER) …
Delivery Method: Via Email Product: Drugs WARNING LETTER December 10, 2024 RE: 695607 Dear Summit Research Peptides: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https …
Summary CDER researchers are developing an approach that enables sharing and analyzing large volumes of cardiac electrophysiology in vitro data and streamlines the analysis and interpretation of these nonclinical data to support clinical cardiac safety …
Español If you have questions about COVID-19 vaccines, the best person to ask is a health care professional, like your doctor. Fact: Blood donated by individuals who have received an FDA-approved/authorized COVID-19 vaccine and meet all required …
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 …
Historically, for topical drug products applied to the skin, bioequivalence (BE) has often been established based on comparative clinical endpoint BE studies. However, such studies are expensive and time-consuming, potentially involving hundreds to …
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 December 13, 2024, the Food and Drug Administration approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics, Inc.), a programmed death ligand-1 (PD-L1) blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or …
