Blog
Save the date: IMDMC Medical Device event at the Indiana Statehouse February 15, 2017
On February 15, 2017, the Indiana Medical Device Manufacturers Council (IMDMC) will host the annual Medical Device Exhibit and Breakfast at the Indiana Statehouse. This event provides the opportunity to interact with state and federal officials about the industry. To...
New FDA draft guidance points to problems with multiple endpoints in clinical trials
The US FDA released draft guidance this week on the “problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in drug and biologic clinical trials,” Zachary Brennan of RAPS reports. The FDA...
21st Century Cures Act: potential impact on the clinical research landscape
The historic 21st Century Cures Act, written into law last December, is a 362-page bill comprised of several initiatives impacting the life sciences industry. The allocation of $4.8 billion for the “Cancer Moonshot” portion of the bill won over most headlines during...
Happy Holidays from the Pearl team
Over the past two weeks, the Pearl team celebrated the holiday season with various “12 Days of Christmas” activities. Events ranged from reindeer racing to gingerbread house building with plenty of company pitch-ins along the way. [gallery...
FDA finalizes Guidance for Electronic Informed Consent
December 2016 – The U.S. Food and Drug Administration (FDA) finalized its guidance intended for institutional review boards (IRBs), investigators, and sponsors engaged in (or responsible for) oversight of human subject research under the Department of Health and Human...