The FDA denied a United Therapeutics petition urging the agency to reject ANDAs for combination products referencing the company’s hypertension drug Tyvaso (treprostinil). Read More
The FDA issued Summit Medical a Form 483, citing issues with CAPA and incoming product acceptance procedures as well as process validation shortcomings. Read More
The FDA cited device manufacturer Sybaritic of Bloomington, Minnesota following a Feb. 22 to March 7 inspection for failing to comply with the terms of a consent decree. Read More
The FDA should clarify which device types will be eligible for its abbreviated 510(k) pathways, AdvaMed said in a written comment on the agency’s draft guidance. 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