Malcolm Spicer, Managing Editor – US
Latest From Malcolm Spicer
Guidance extends through Jan. 6 enforcement discretion for formula products cleared for sales under temporary guidance FDA announced in May. Further extensions possible for firms taking steps toward lawful marketing of products in US, agency says.
Latest plan, agency’s second annual following debut in 2021, lists monograph activities FDA intends to address over next three years. “FDA’s decision‐making regarding which activities to place on the forecast is generally guided by public health priorities,” it says.
Senate votes down Illinois Democrat’s proposal to amend stopgap appropriations bill with language calling for establishing mandatory products listing program in FDA. But proposal to give FDA MPL authority likely will return in Congress, says Natural Products Association.
Submissions go to one of two addresses: OMORs, for changes or additions to monograph formulations and indications, go to the CDER NextGen Portal, and data, information and public comments on proposed or interim final orders go to OTC Monographs@FDA.
With current user fee package as well all federal spending programs for FY2022 expiring on 30 September, House and Senate committee leaders reach agreement on FDA user fee reauthorization included in a continuing resolution to extend federal spending at current levels through 16 December.
Gathering GMP information can be as problematic for agency as keeping tabs on all supplements available to US consumers. “Just to be clear, FDA believes we have a data gap in understanding the extent of the dietary supplements in the marketplace,” says ODSP Director Cara Welch.