Libby Laboratories, Inc. – 708259

by Pill Pals Customer Service | 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 Pill Pals Customer Service | 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 Pill Pals Customer Service | 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,...

FDA Public Meeting: BsUFA III Regulatory Science Program Interim Publi

by Pill Pals Customer Service | Jul 7, 2025 | News

On This Page Date: September 18, 2025 Time: 9:00 a.m. – 3:00 p.m. ET Under the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 to 2027 (BsUFA III), FDA committed to piloting a regulatory science program that focuses on: 1)...

Drug Trials Snapshot: ROMVIMZA

by Pill Pals Customer Service | 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...