Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) Guidance for Industry Control of Nitrosamine Impurities in Human Drugs Guidance for Industry Subscribe for email […]

Is the Critical Path Innovation Meeting a PDUFA meeting? The main goal of the CPIM is a collaborative discussion about emerging science, tools and methods to […]

Reference #: FEI 1317759 Product: Drugs Recipient: Recipient Name Mr. Michael P. Borrello Recipient Title Executive VP of Operations Ultra Seal Corporation 521 Main St,New Paltz, […]

Delivery Method: Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Dennis P. Borrello Recipient Title President and CEO Ultra Seal Corporation 521 Main StreetNew Paltz, NY […]

Hello. In this presentation, I will discuss the Critical Path Innovation Meeting, otherwise known as CPIM,  program, including goals of the program, how to request a […]

Department of JusticeU.S. Attorney’s OfficeDistrict of Puerto Rico FOR IMMEDIATE RELEASEWednesday, September 25, 2024 HHS OIG and FDA are in charge of the investigation SAN JUAN, […]

BPC-157 503A September 29, 2023 Compounded drugs containing BPC-157 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to […]