Innovating For better Health

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 8, 2022

While drugs and devices differ in their development, clinical trial phases and regulatory guidelines, the most important difference is that medical devices do not achieve their principal action by pharmacological means.

whitePaper | October 14, 2022

COVID-19 has been a catalyst for a huge amount of change across the pharmaceutical industry, acting as an accelerant for progress in its use of digital technology and prompting a reassessment.

whitePaper | November 18, 2022

Research by McKinsey on the operational practices of more than 25 global pharmaceutical manufacturers found that the top companies are more than twice as productive as their counterparts.

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 15, 2022

Because vitamin D receptors are present in most cells in the body, its active form has potent effects on the growth and differentiation of many types of cells, meaning that vitamin D