Why drug manufacturing needs to become more flexible

whitePaper | November 25, 2022

To meet the needs of a growing range of external stakeholders, many life science companies are changing the ways that they disseminate information.

whitePaper | June 5, 2022

Although our growing scientific understanding and improvements made in medical technology lead to significant advances in human health and wellbeing, many therapy strategies remain insufficient,

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 | 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 | April 7, 2022

The United States defines a rare disease as a condition affecting fewer than 200,000 people in the country or one in which “there is no reasonable expectation” of recovering research and development costs.1 Examples of rare diseases include genetically-linked cancers, cystic fibrosis, and debilitating pediatric conditions like Gaucher disease and spinal muscular atrophy

whitePaper | June 28, 2022

CF is a rare, autosomal recessive disease caused by mutations in the cystic fibrosis transmembrane regulator (CFTR) gene that encodes the CFTR protein, an anion channel normally present in the epithelial membrane.1,2