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FDA $6.1Bn Budget Proposal Includes $28M From OTC Monograph User Fees

 
• By Malcolm Spicer

White House budget request published March 11 proposes a $643m increase in FDA's total FY 2020 funding, with $281m of the increase from FY 2019 in user fees and $362m from the agency's budget authority. Request includes OTC monograph user fees again, increased by $6m.

Better America Budget Book

The $6.1bn for FDA's fiscal year 2020 funding the Trump administration requests includes $28m in OTC monograph user fees that would be established in legislation to overhaul the agency's system that allows marketing of the vast majority of nonprescription drugs available.

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The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Plenty For Industry To Do As EU Wastewater Directive Faces Legal Challenges

 
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Doctors In The House: Sunscreen Innovation Diagnoses From Health Subcommittee

 
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Marketplace Results After FDA OTC Monograph Overhaul Rely On OMUFA Reauthorization

 
• By Malcolm Spicer

“If this doesn’t get reauthorized, look at the number of the ingredients out there, the number of products, what would happen all those products out there for the consumer, on that shelf, in the drugstore or someplace?” says Rep. Bob Latta during House hearing.

More from Policy & Regulation

EU Parliament Agrees To Postpone Due Diligence And Sustainability Reporting Rules

 
• By David Ridley

Speaking at a recent AESGP webinar, sustainability expert Onur Durmus called the the European Commission’s “Omnibus” proposals - designed to simplify ESG reporting rules and recently supported by EU Parliament - a “positive development” for the European consumer health industry.

Over The Counter: Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.

Doctors In The House: Sunscreen Innovation Diagnoses From Health Subcommittee

 
• By Malcolm Spicer

Energy and Commerce Health Subcommittee members, including several health care professionals, make clear their concerns about the US sunscreen market during hearing on reauthorizing FDA’s OMUFA program.