“Port shopping” targeted
This article was originally published in The Tan Sheet
Executive SummaryFDA wants to stop food and dietary ingredients denied entry into the U.S. at one port from gaining access at another port through the practice of port shopping, according to a proposed rule in the Sept. 18 Federal Register. The proposal would require food shippers to clearly label food as being "refused entrance" in the U.S. if an inspector denies the import for safety concerns. This will signal other ports not to allow the imports. Comments are due Dec. 2. The proposal would implement part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 that criminalized port shopping, the American Herbal Products Association says
You may also be interested in...
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.