Alta Sciences

MAY 15, 2023

and Canadian CPUs with compounding pharmacies, that are integrated with our bioanalytical labs and manufacturing and analytical campus. Altasciences has U.S. In fact, one of our bioanalytical laboratories is located within a few minutes' drive of our Montréal CPU, contributing to speedy data acquisition.

Drug Development 52

Drug Development Clinical Trials Compounding Pharmacies Laboratories 52

Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.”

FDA 40

FDA Pharmacy Production Drugs 40

The Pharma Data

MAY 7, 2021

Catalent snaps up Promethera’s cell therapy subsidiary, complete with a Belgian plant to help scale plasmid DNA efforts ( Endpoints ). Goldman Sachs jumps aboard Bain-backed 503(b) compounding pharmacy with a $275M debt loan to supply hospitals ( Endpoints ). . Pharma & Biotech.

Vaccine 52

Vaccine Compounding Pharmacies Regulations Drugs 52

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

FDA 40

FDA Science Biosimilars Clinical Trials 40