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May 17, 2022

Specialty Process Labs LLC – 624281 – 05/03/2022

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, […]
May 16, 2022

President’s Emergency Plan for AIDS Relief (PEPFAR)

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 […]
May 16, 2022

Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production – Level 2 revision

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 […]
May 16, 2022

Generic Drug Facilities, Sites and Organization Lists

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 […]
May 12, 2022

FDA Approves Oral Form for the treatment of adults with amyotrophic lateral sclerosis (ALS)

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 […]
May 12, 2022

FDA’s Overview of Catalyst Pharms., Inc. v. Becerra

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 […]
May 12, 2022

From Our Perspective: FDA’s Role in Helping a Critical Medical Isotope Meet Sufficient Supply in the US for First Time

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, […]
May 11, 2022

Generic Drugs Forum 2021: Lifecycle of a Generic Drug – 04/28/2021

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 […]
May 10, 2022

CDER Launches New Accelerating Rare disease Cures (ARC) Program

[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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