How Specialty Pharmacy Can Drive Better Outcomesin Multiple Sclerosis

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 9, 2022

Randomized, double-blind clinical trials are the gold standard for adequate and well-controlled studies in modern times. However, prior to the late 1940s, randomization and blinding were not used in medicine and as result, bias was common.

whitePaper | March 15, 2022

Successes in 2021 – New active substance drug launches

whitePaper | March 27, 2023

European countries have been experiencing medicine shortages due to disruptions in the supply chain. Reshoring the productions of active pharmaceutical ingredients (APIs) is considered as an approach to secure the supply.

whitePaper | December 29, 2022

Regulatory teams at life science companies are finding that effective regulatory information management (RIM) has become critical to their operations.

whitePaper | September 16, 2022

T wice a year, we survey the cell and gene therapy landscape and ARM’s initiatives to advance the sector and provide an update to our members.