Precision Material Creates New Applications and Markets

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 | 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.

whitePaper | September 8, 2022

Charles Darwin famously said on survival, "It is not the strongest of the species that survives, nor the most intelligent; it is the one most adaptable to change." Resilience has become an essential message in today's post-covid, next-normal world.

whitePaper | January 21, 2023

Emerging Diseases Require New Tools Medicines to treat and prevent infectious diseases cover a broad range of modalities from dosed therapeutics to vaccines. Biotherapeutics require a detailed knowledge of binding sites, or epitopes, on their respective antigens.

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 | June 22, 2023

Generic medicines are the backbone of the U.S. prescription drug market, supplying more than 9 out of every 10 prescriptions. And the availability of generic medicines overall is remarkably stable even during challenges such as the COVID-19 pandemic.