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 nervous […]

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 Immediate Release: December 17, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the […]

12-16-2024 UpdateFDA adds a Boxed Warning, our most prominent warning, to highlight the known risk of rare but serious liver injury associated with use of menopause […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

3/19/2024 Proposed Rule Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, […]

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER December 10, 2024 RE: 695607 Dear Summit […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Andrew Pierce Xcel Research LLC 1309 Coffeen Ave., Suite 12238Sheridan, WY 82801United States [email protected] Issuing Office: Center […]

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, […]