Compliance with Mobile Medical Devices Discussed in MedTech Intelligence
Device companies seeking to develop products that include a mobile app must ensure regulatory compliance with product and data safety.
Top Five Hurdles for FDA ANDA Submissions and Approvals
By Radhika Rajagopalan The FDA Generic Drug User Fees Amendment (GDUFA) has entered a relatively matured stage with applicants of Abbreviated New Drug Applications (ANDAs) experiencing a timely review and communications regarding their submissions packet, as well as...
Garth Kahl
Garth Kahl has a long career history working with organic crop and livestock farms and processing throughout the U.S. and Latin America to ensure compliance under NOP, EC 834/2007, Mexico LPO, COR and JAS standards. He assists EAS clients with all aspects of organic...Couch Authors Article on GLPs for Dietary Supplement Contract Labs
Supplement brands that partner with contract labs must ensure they are following good lab practices and other quality assurance programs.
