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Libby Laboratories, Inc. – 708259

by | Jul 8, 2025 | News

Delivery Method: VIA Electronic Mail Reference #: 320-25-87 Product: Drugs Recipient: Recipient Name Ms. Susan Carol Libby President Recipient Title President Libby Laboratories, Inc. 1700 Sixth StreetBerkeley, CA 94710United States Issuing Office: Center for Drug...

Science and Research

by | Jul 8, 2025 | News

The U.S. Food and Drug Administration is responsible for protecting the public health through the rigorous review of applications for licensure of biological products, including biosimilar and interchangeable biological products. In addition, FDA is responsible for...

Biosimilars Research: Awards

by | Jul 7, 2025 | News

The bioassay initiative: enhanced biosimilar testing capabilitiesOPQ/OPQRMay 20232-3 yearsResearch Priority C: Define best-practices for assessing and reporting quality attributesEnhancing CDER bioassay capabilities to additional attributes to provide definition,...

Drug Trials Snapshot: ROMVIMZA

by | Jul 7, 2025 | News

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar...

Verify Wholesale Drug Distributor Licenses

by | Jul 7, 2025 | News

Valid License is Required Under the LawPrescription drugs should only be purchased from wholesale drug distributors with a valid license in the U.S. and who are authorized by law. Unlicensed and unauthorized trading partners put patients at risk of taking unsafe,...

Exela Pharma Sciences, LLC – 709859

by | Jul 3, 2025 | News

Delivery Method: Via Email Reference #: 320-25-88 Product: Drugs Recipient: Recipient Name Phanesh Koneru, PhD, LL.M. Recipient Title President and CEO Exela Pharma Sciences, LLC 1245 Blowing Rock BlvdLenoir, NC 28645-3618United States Issuing Office: Center for Drug...