Potential measures to facilitate the productions of activepharmaceutical ingredients (APIs)

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 | July 21, 2022

The growing costs of the diabetes epidemic in the U.S. are staggering. Over 37 million Americans around 11% of the population now have diabetes, and according to a recent study, over 60 million Americans are expected to have the disease by 2060.

whitePaper | March 28, 2023

About 70% of new chemical entities (NCEs) are highly insoluble.1 It’s a fact that troubles small biotechnology companies and other drug manufacturers. Indeed, insoluble drugs present a wide range of challenges during development and, if not addressed, can ultimately render drugs ineffective in patients.

whitePaper | March 14, 2022

Over the past several years, biologics have gained significant traction in the pharmaceutical industry, representing more than $150 billion in global sales in 2013. By 2020 they are predicted to generate $290 billion in revenue and comprise 27 percent of the pharmaceutical market.i

whitePaper | October 20, 2022

When the first Nokia and Motorola cell phones that were affordable and small enough to fit in your pocket hit the market, they not only changed how we viewed phone technology but how we communicated.

whitePaper | May 26, 2022

The medical device and pharmaceutical industries each share in a mission to improve health outcomes, from prevention to intervention. As a result of this shared mission, integration and overlap between these two industries has been taking place for decades.