Regulation/Legislation (Health)
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Regulation
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Latest From Health & Regulation
New UK Health Secretary Wants More OTCs Available And Greater Role For Pharmacists
More medicines available without a prescription and more responsibility for community pharmacists are two of the goals set out by the UK's new Secretary of State for Health and Social Care.
US FDA Adds Pediatric Cough/Cold Dosing, Ipecac GRASE To Latest OTC Monograph Forecast
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.
Durbin Lights Supplement MPL Flare In US Senate
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.
Legislation
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Latest From Health & Legislation
US FDA Adds Pediatric Cough/Cold Dosing, Ipecac GRASE To Latest OTC Monograph Forecast
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.
Durbin Lights Supplement MPL Flare In US Senate
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.
US OTC Monograph Reform Enters Electronic Age With Draft Guidance On Submission Formats
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.
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