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October 26, 2020

Compounding Information for States

FDA’s compounding program closely collaborates with state officials. FDA collaborates with state officials in a variety of ways, including by sharing information about compounders who engage […]
October 26, 2020

From Our Perspective: The Orange Book at 40: A valued FDA resource continually enhanced by user input

Captain Kendra Stewart, Orange Book supervisor, discusses the Orange Book’s 40th Anniversary October 31, 2020, marks the 40th anniversary of the first official publication of the […]
October 26, 2020

FDA Approves Companion Diagnostic to identify NTRK fusions in solid tumors for Vitrakvi

On October 23, 2020, the Food and Drug Administration approved the next-generation sequencing (NGS)-based FoundationOne CDx test (Foundation Medicine, Inc.) as a companion diagnostic to identify […]
October 26, 2020

What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD

Some CBD Products are Being Marketed with Unproven Medical Claims and Could be Produced with Unsafe Manufacturing Practices Unlike the FDA-approved CBD drug product, unapproved CBD […]
October 23, 2020

Coronavirus (COVID-19) Update: Daily Roundup October 23, 2020

For Immediate Release: October 23, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
October 23, 2020

Efficient Laboratories, Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination

Summary Company Announcement Date: January 31, 2020 FDA Publish Date: January 31, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description due to Microbial Contamination […]
October 23, 2020

Developing and Manufacturing Drugs Including Biologics

This material is intended to be a helpful resource that consolidates information relevant for drug manufacturers making products for the U.S. market. It is not a […]
October 23, 2020

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry

Docket Number: FDA-2019-D-4212 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Office of Regulatory Affairs This guidance […]
October 23, 2020

Foothills Professional Pharmacy, LTD – 598883 – 09/22/2020

Reference #: 598883 Recipient: Division of Pharmaceutical Quality Operations IV United States FOOTHILLS PROFESSIONAL PHARMACY, LTD. September 22, 2020 Via Certified MailReturn Receipt RequestedVia E-MailORAPHARM4 [email protected] […]
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