FDA Creating Innovation Office to Speed Drug Development
January 8, 2019
By Neozene

The FDA is creating an office of drug development science to cut the cost of bringing new medicines to patients, BioCentury reports. Staff at the office will create tools that sponsors and the FDA can use to streamline the development and regulatory assessment of drugs. FDA Commissioner Scott Gottlieb, M.D., is due to reveal the new office later Tuesday via videolink at the J.P. Morgan Healthcare Conference. In creating the office, Gottlieb thinks the FDA can leverage improved understanding of biomarkers and other advances to build tools that take some of

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Medical device R&D spending expected to rise through 2018
July 27, 2017
By Neozene

An Emergo survey of medical device companies finds that a higher percentage of smaller firms plan to increase their research and design spending over the next year than mid- and large-sized firms. The survey of 543 medical device executives in North America, Europe and Asia revealed not only planned R&D spending differences between smaller respondents (those with 50 or fewer employees) and larger firms (those with 50 or more employees), but also different business priorities driving those R&D spending plans. Medical device R&D spending overall set to increase in 2018

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Consent Decrees
July 6, 2017
By Devin McElroy

The FDA, this morning, issued a press release for a consent decree issued against Medistat by a U.S. District Judge (see attached article for details). What is a consent decree and what actions cause one to be issued? A consent decree is requested by the FDA and issued by a Federal Judge against a company that has had numerous, unresolved violations against U.S. regulations for medical device or pharmaceutical manufacturing. Typically this process starts years before with a series of FDA Form 483 (Notice of Inspection) findings issued against a

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