Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Ricky L. Cox Recipient Title President and CEO Specialty Process Labs LLC 1030 E. Lone Cactus Dr.Phoenix, […]
Explore the PEPFAR Interactive Database Search for information about tentatively approved and approved antiretroviral drugs that are eligible for procurement under the President’s Emergency Plan for […]
Docket Number: FDA-1998-D-0019 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance for industry provides the Agency’s current thinking on how to […]
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 […]
Action FDA has approved Radicava ORS (edaravone) oral suspension for the treatment of adults with amyotrophic lateral sclerosis (ALS). Radicava ORS is an orally administered version […]
On September 30, 2021, the U.S. Court of Appeals for the 11th Circuit issued a decision in Catalyst Pharms., Inc. v. Becerra (Catalyst)—a decision that impacts […]
By: Joseph Rajendran, M.D. (Medical Doctor), FASNC (Fellow of the American Society of Nuclear Cardiology), FACNM (Fellow of the American College of Nuclear Medicine), Medical Officer, […]
Presentation Title Presenter(s) Keynote from Sally Choe, Director, Office of Generic Drugs (OGD) Sally ChoeDirectorOffice of Generic Drugs (OGD)CDER Office of Pharmaceutical Quality (OPQ) Update Sau […]
[5/10/2022] FDA’s Center for Drug Evaluation and Research (CDER) announced the launch of the new Accelerating Rare disease Cures (ARC) Program. The vision of CDER’s ARC […]
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