Are you a digital health innovator? The FDA wants you for a new entrepreneur-in-residence program
The initiative is intended to generate insights and feedback for the FDA's Pilot Pre-certification program.
The initiative is intended to generate insights and feedback for the FDA's Pilot Pre-certification program.
FDA has announced two more initiatives designed to foster greater generics competition, a key priority for new commissioner Scott Gottlieb.
Gabby Everett, the site director for BioLabs Pegasus Park, offered a tour of the space and shared some examples of why early-stage life science companies should choose North Texas.
In a blog post this week, Scott Gottlieb highlighted the Digital Health Innovation Plan that will clarify how the FDA regulates digital medical devices and apps.
The FDA's move to request Endo Pharmaceuticals to remove its opioid drug Opana ER (oxymorphone hydrochloride) from the market is a first for the regulator.
Gottlieb takes over a post in which he will be called upon to address escalating drug prices and the opioid epidemic as the FDA faces increasing pressure to greenlight drugs faster and do more with less, if Trump's budget plans come to fruition.
In his confirmation hearing, Trump's nominee for FDA Commissioner Scott Gottlieb responded to his alleged conflicts of interest, questions about the opioid epidemic and more.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Scott Gottlieb, 44, has deep ties to the pharma industry as an investor and consultant but he has also worn many hats in a career that included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.
Anonymous sources have once again stolen President Trump's thunder, informing Reuters that Scott Gottlieb will soon be announced as the nominee for FDA commissioner. Gottlieb is a relatively safe option, though he has written extensively about a need for agency reform.