Posted: 16 Jul 2013 07:50 AM PDT
By James E. Valentine* & Anne K. Walsh –
Despite Congress giving FDA new powers to regulate the integrity of the drug supply chain, the globalization of the pharmaceutical market continues to present clear challenges for the Food and Drug Administration (“FDA”). FDA’s new authorities are outlined in Title VII of the Food and Drug Administration Safety and Innovation Act of 2012 (“FDASIA”). (A comprehensive overview of Title VII can be found in our detailed summary and analysis of FDASIA here). FDA held a meeting last Friday as part of the process for implementing FDASIA. During the first portion of the meeting, FDA updated the public on the progress it has made to date. Commissioner Hamburg and other FDA officials touted the recent release of two documents related to enforcement under Title VII:
continue to read at FDA Continues to Solicit Comments on Drug Supply Chain Issues |
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Wednesday, July 17, 2013
FDA Continues to Solicit Comments on Drug Supply Chain Issues
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