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October 27, 2020

Quimica Magna de Mexico, S.A. de C.V. – 608751 – 10/15/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Jorge Varela Recipient Title CEO Quimica Magna de Mexico, S.A. de C.V. Telares No. 130La Aurora25298 […]
October 27, 2020

Shilpa Medicare Limited – 607877 – 10/09/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Vishnukant Chaturbhuj Bhutada Recipient Title Managing Director Shilpa Medicare Limited #12-6-214/A1 Hyderabad RoadRaichur 584135KarnatakaIndia Issuing Office: […]
October 27, 2020

Inter-governmental Working Meeting on Drug Compounding, October 10-11, 2019

On October 10-11, 2019, FDA convened its eighth inter-governmental working meeting of state government officials. Attendees included officials from state boards of pharmacy and state health […]
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 […]
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