Model-based Drug Development for Generic Products

whitePaper | December 31, 2021

The scope of this white paper includes GMPs relevant for mass manufacturing/batch53 processing of products intended for widescale retail marketing. Starting materials and 54 packaging components for drug products

whitePaper | May 25, 2023

CDER’s mission is to ensure that human drugs are safe and effective, meet established quality standards, and are available to patients. To advance this mission, FDA’s Pharmaceutical Quality for the 21st Century Initiative promotes an efficient, agile, and flexible pharmaceutical manufacturing sector that reliably produces quality drugs without excessive regulatory oversight.

whitePaper | December 13, 2022

Viral vectors are a critical part of the advanced therapies supply chain as they are used to introduce the gene of interest, whether that’s into a cell intended for therapeutic gene transfer or for direct viral-mediated gene transfer into the patient.

whitePaper | July 7, 2022

The full drug target profile identification is many times a necessary step in drug development process. Recently, the move to a more holistic approach in drug discovery has resulted in the increasing use of cell-based assays to discover new biologically active small molecules.

whitePaper | March 1, 2023

Shortages of critical medications continue to rise—including drugs used in hospital emergency rooms and to treat cancer, prescription medications, and even common over-the-counter treatments like children’s cold and flu medicine.

whitePaper | November 18, 2022

To realize the full potential of RWD, we must put the patient at the center and truly understand each patient’s unique circumstances over time. It’s certainly a tall order when the data we need is scattered across siloed systems and guarded by applicable and necessary patient privacy regulations.