FDA Commissioner Scott Gottlieb offered assurances about the agency’s approval of an OTC asthma inhaler that was previously pulled from the U.S. market in 2011. Read More
The FDA hit three foreign device manufacturers with warning letters, calling the firms out for quality system violations that led to adulterated products. Read More
The European Commission added four new products it considers devices to its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, including several related to contraception. Read More
Three devicemakers drew 483s for quality system and other failures observed during FDA inspections. Read More
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 – Fax (703) 538-7676 – Toll free (888) 838-5578.
Copyright ©2018. All Rights Reserved.
Design, CMS, Hosting & Web Development :: ePublishing