FDA's Draft Track and Trace Guidance Is Too Late As Serialization Systems Are Already In Place - Industry
Executive Summary
The pharmaceutical industry sees many problems with US FDA’s draft guidance on product serialization to comply with the Drug Supply Chain Security Act of 2012, including requirements for “absolute uniformity.” Moreover, it’s coming out too late for companies that long ago set up serialization IT systems to comply with a November deadline.
You may also be interested in...
Gottlieb: FDA May View State Drug Wholesaler Licensure As Fully Preempted Under DSCSA
US FDA Commissioner Scott Gottlieb says Congress intended to preempt all state licensure laws that were not identical to federal laws for licensing wholesalers and third-party logistics providers under the Drug Supply Chain Security Act.
Track And Trace: Stakeholders Beg FDA For Early Guidance
Drug manufacturers, wholesale distributors and pharmacies urge FDA to issue guidance ahead of the agency’s November deadline on exchanging information about a drug as it moves through the supply chain.
Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”