Docket Number: FDA-2013-D-0447 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Oncology Center of Excellence This guidance […]
Below you will find a compressed data file of the Drugs@FDA database. It does not include the scripts (programming) we use to produce the online version […]
For Immediate Release: February 13, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the […]
FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma On February 13, 2024, the Food and Drug Administration approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, […]
On February 13, 2024, the Food and Drug Administration approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of […]
Annual facility fees and Generic Drug Applicant Fees are due October 1st of each applicable FY. Content current as of: 02/13/2024 Regulated Product(s) Topic(s)
Generic Drug Facilities, Sites and Organization Lists | FDA In this section: Generic Drug User Fee Amendments Home For Industry FDA User Fee Programs Generic Drug […]
Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Matthew Lucks Synthetix Inc. DBA Helix Chemical Supply 558 Grand Concourse Suite 279Bronx, NY 10451United States [email protected] […]
Product: Drugs Recipient: Recipient Name John Willimann Recipient Title President Global Life Technologies Corp. 4608 N. Park Avenue, 2nd floorChevy Chase, MD 20815United States [email protected] Issuing […]
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