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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.

Europe United Kingdom

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.

FDA Drug Approval Standards

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.

Dietary Supplements FDA
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Legislation

Set Alert for Legislation {Health}

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.

FDA Drug Approval Standards

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.

Dietary Supplements FDA

US OTC Monograph Reform Enters Electronic Age With Draft Guidance On Submission Formats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.

FDA Guidance Documents
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