FDA seeks input on proposed predecisional process for device trials

06/20/2013 | Clinica (subscription required)

The FDA has released draft guidance governing a new voluntary program that would help clinical trial sponsors assess, prior to submitting an investigational device exemption application, whether the design of their pivotal study would lead to marketing approval. The guidance is up for comment through Sept. 12.

View Full Article in:

Clinica (subscription required)

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Manager, Business Conduct
Gilead
Foster City, CA
Sr. Compliance Director Ethics and Compliance
Medtronic
Fridley, MN
Product Patent Attorney
Gilead
Foster City, CA
Employment Counsel
Gilead
Foster City, CA
Junior to Mid-Level FDA Associate
Morgan Lewis
Washington, DC