The Annual Clinical Trials Round-up 2021

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 | October 25, 2022

To confirm the suitability of empty hard capsules for use in the application of quality-by-design (QbD) in the development and manufacturing of finished pharmaceutical products, the quality target product profile (QTPP) defined by eight critical quality attributes (CQA’s) was examined.

whitePaper | May 11, 2022

CDER is taking another step towards realizing the vision for pharmaceutical quality in the 21st century: a maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.

whitePaper | October 7, 2022

The Drug Supply Chain Security Act is one component of the DQSA. This particular act requires the FDA to implement a national track-and-trace system by which manufacturers must affix product identifiers (barcodes) to each package of product that is introduced into the supply chain.

whitePaper | January 3, 2022

There are many factors that can prevent a patient from being able to obtain the medicine they need, ranging from selective marketing decisions by companies to products being too expensive or pharmacy stock-outs

whitePaper | April 7, 2022

Year after year, the Life Sciences industry expands at a breakneck pace, with pharmaceutical development leading the way.