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Malcolm Spicer

Malcolm Spicer, Managing Editor – US

Washington, DC
Malcolm Spicer is lead analyst for Pharma intelligence | informa's coverage of the consumer health care products industries. He provides comprehensive and insightful reporting on manufacturing, marketing, regulation, legislation, financial and research news about the nonprescription drug and nutritional product industries. He has worked in this post for 10 years and previously reported for other publications on regulation of the health care industry, on the telecommunications and internet technologies and on the US energy market.

Latest From Malcolm Spicer

US Extends Enforcement Discretion For Infant Formula Production With Guidance For Compliance

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.

Dietary Supplements FDA

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US OTC Monograph Reform Enters Electronic Age With Draft Guidance On Submission Formats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

US Budget Stopgap, FDA User Fee Reauthorization On Tap Minus Supplement MPL Program

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.

User Fees FDA

US FDA Targets Expanding Conduit For Supplement GMP Compliance Information

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.

Dietary Supplements FDA
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