U.S./EUROPEAN MUTUAL RECOGNITION TALKS FOR DEVICE APPROVALS ON HOLD UNTIL 1997 AT EARLIEST WHILE AGENCY EVALUATES THIRD-PARTY REVIEW PILOT PROGRAM
This article was originally published in The Gray Sheet
Medical device mutual recognition agreement negotiations between FDA and the European Union are on hold until 1997 at the earliest, according to FDAers and U.S. trade officials. Talks were delayed after FDA topsiders rejected a draft "concept paper" outlining a device approval MRA strategy that was negotiated by FDA and EU representatives in Washington, D.C. in November 1995.
You may also be interested in...
After urging the US Congress to act on updating Medicare Part D, the Association for Accessible Medicines has welcomed the decision to update Part D by the Centers for Medicare & Medicaid Services of the US Department of Health and Human Services.
Dr Reddy’s signals a sharp step up in ambitions at home, propelled by building leadership in 10 therapy segments and an “India-first” approach for specialty products. Uptick in the China business and the potential launch of a Russia-partnered COVID-19 vaccine were other aspects of the business discussed at JPM.
“You can’t just live off the brand equity anymore,” warned J&J's Consumer Health's Minoj Raghunandanan during the ‘Advancing Trust in the Self-Care Industry’ webinar co-hosted by the Global Self-Care Federation and HBW Insight. “You’ve got to continue to build that trust between consumers and products day-in day-out.”