The term “real-world evidence” is widely used by those who develop medical products or
who study, deliver, or pay for health care, but its specific meaning is elusive. We believe it …

Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both | NEJM Skip to main
content NEJM Group Follow Us Facebook Twitter Instagram YouTube LinkedIn Prepare to …

This review further clarifies the concept of pharmaceutical quality by design (QbD) and
describes its objectives. QbD elements include the following: (1) a quality target product profile (…

Societal expectations about drug safety and efficacy are rising while productivity in the
pharmaceutical industry is falling. In 2004, the US Food and Drug Administration introduced the …

There has been much recent discussion about the advent of “personalized medicine,” but
controversy exists over its exact definition; how, when, and whether it will be brought about, …

The Food and Drug Administration (FDA) regulates pharmaceutical drug products to ensure
a continuous supply of high-quality drugs in the USA. Continuous processing has a great …

Advances in therapeutic strategies for Alzheimer's disease that lead to even small delays in
onset and progression of the condition would significantly reduce the global burden of the …

Background There is an urgent need to determine whether oversulfated chondroitin sulfate (OSCS),
a compound contaminating heparin supplies worldwide, is the cause of the severe …

Recently, certain lots of heparin have been associated with an acute, rapid onset of serious
side effects indicative of an allergic-type reaction. To identify potential causes for this sudden …

Background: In the US, manufacturers seeking approval to market a generic drug product must
submit data demonstrating that the generic formulation provides the same rate and extent …