In Brief: IMDMC petition
This article was originally published in The Gray Sheet
IMDMC petition: Rep. David McIntosh (R-Ind.) urges FDA "to move forward" on a response to the Indiana Medical Device Manufacturers Council's May 1995 citizens petition on the agency's use of guidance documents ("The Gray Sheet" May 22, 1995, p. 3). In an Aug. 6 letter to FDA Deputy Commissioner for Policy William Schultz, the Indiana Republican notes that "it has been well over a year" since the trade group submitted its petition and recommends FDA "set a completion date" for the response. In addition, McIntosh asks for a status report on the IMDMC issue, "an outline for FDA's future plan for developing a response to the petition," and a "summary of the anticipated form(s) of FDA's response to the full range of rulemaking and guidance issues raised by the petition." FDA has proposed a series of "good guidance practices" to address several of the issues in the petition ("The Gray Sheet" March 11, I&W-2); the agency hopes to finalize the GGPs before the end of the year. FDA's device center has implemented its own guidance policy until the agency-wide GGPs are completed...
You may also be interested in...
The UK has approved the mRNA-based vaccine just nine days after receiving the final Phase III results from Pfizer.
As the MHRA prepares to grant approval to the Oxford/AstraZeneca vaccine, Wockhardt is set to supply 100 million doses for the UK government’s own use and its WHO commitments. The company is also in talks with global vaccine developers to manufacture their COVID-19 vaccines for emerging economies
A combined final opinion on the European Chemicals Agency’s proposed microplastic restriction is expected from ECHA committees by year-end, at which point the European Commission will consider whether and when microplastic must be removed from all leave-on cosmetic products marketed in the EU.