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Wave Miami LLC – 590422

by | Mar 24, 2025 | News

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Andres Rivera Wave Miami LLC 1434 E. Hunting Park AvenuePhiladelphia, PA 19124United States Issuing Office: Division of Pharmaceutical Quality Operations I United States WARNING LETTERCMS #590422...

The Wine of Circe

by | Mar 24, 2025 | News

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia, USA Sir...

Baja Fur S.A. de C.V. – 590791

by | Mar 24, 2025 | News

Delivery Method: VIA UPS Reference #: 320-20-12 Product: Drugs Recipient: Recipient Name Mr. Eric Chen Baja Fur S.A. de C.V. Markwins Beauty Brands, Inc. 22067 Ferrero ParkwayCity of Industry, CA 91789United States Issuing Office: Center for Drug Evaluation and...

Kalchem International, Inc. – 607098

by | Mar 24, 2025 | News

Reference #: FEI 1000149906 Product: Drugs Recipient: Recipient Name Ms. Kalyn R. Tabor Recipient Title President, Owner Kalchem International, Inc. 224 S. Main St Ste BLindsay, OK 73052United States Issuing Office: Office of Pharmaceutical Quality Operations,...

FDA Roundup: March 21, 2025

by | Mar 21, 2025 | News

For Immediate Release: March 21, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Thursday, the FDA approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G)...

COA Grant Program

by | Mar 21, 2025 | News

Patient input can help inform the therapeutic context for regulatory review. Patient input also can inform the selection of clinical outcomes, ensure the appropriateness of instruments used to collect trial data, and help ensure that investigations of the effect of...