OR WAIT null SECS
September 15, 2016
Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.
September 12, 2016
The new regulations aim to introduce greater consistency and uniformity in the assessment and approval of medical devices and in-vitro diagnostics across the European Union.
April 06, 2016
The agency has announced the creation of the Combination Products Policy Council to address issues related to combination products.
February 24, 2016
Curida entered into a partnership with René Bommer, PhD, founder and owner of pharmAccel Consulting.
October 20, 2015
The agency gives an update on the regulation of combination medical products.
April 02, 2014
Mark D. Kramer talks about combination products from a regulatory perspective and explains the implications of FDA's final rule on current GMP requirements for combination products.
June 24, 2013
Combination product design takes second prize in the National Collegiate Inventors and Innovators Alliance Biomedical Engineering contest.
May 02, 2013
While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.
October 02, 2012
Fixed-dose combination drug therapies give rise to innovation in solid-dosage formulations and manufacturing.
September 25, 2012
Watson Laboratories has recalled two lots of hydrocodone bitartrate and acetaminophen tablets.