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] […]
October 23, 2020

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

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Pujan A. Patel Recipient Title Owner Foothills Professional Pharmacy, LTD 4545 E. Chandler Blvd., Suite 100Phoenix, […]
October 22, 2020

FDA Approves First Treatment for COVID-19

For Immediate Release: October 22, 2020 Español Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric […]
October 22, 2020

FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—The Science of Safety and Effectiveness

[10/22/2020] FDA recognizes that patients affected by coronavirus 2019 (COVID-19) are in great need of medicines to treat this disease. To help meet this need, the […]
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