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May 17, 2022

CDER Takes Steps to End Prescription Pain Medicine Misuse, Abuse, and Addiction

Pain is a common problem for millions of Americans. Treatment is usually an over-the-counter (OTC) or prescription pain reliever. These medicines help when used as directed […]
May 17, 2022

FDA Seeks to Engage Stakeholders on Key Considerations for a Drug Quality Management Maturity Program

Image By: Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER) and Patrizia Cavazzoni, MD, Director of […]
May 17, 2022

Colorful Products Corporation – 624415 – 05/10/2022

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Brian W. Davidson Recipient Title CEO Colorful Products Corporation 2550 Azurite CircleNewbury Park, CA 91320-1201United States […]
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 […]
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