1. HBW Insight
  2. >>Health
  3. >>Policy & Regulation
  4. >>Legislation

FDA Budget Request Proposes OTC Monograph User Fees And ‘Field Alerts’

 
• By Malcolm Spicer

In addition proposing $28.4m in monograph user fees, agency’s FY 2021 budget justification includes among its legislative initiatives proposing to require "Field Alert Reports" for drug products not marketed under an approved application, such as monograph OTCs.

White House Budget book

The US Food and Drug Administration for the third consecutive year includes OTC monograph user fees in its budget request, but in its fiscal year 2021 proposal the agency for the first time suggests extending its “Field Alert Reports” requirement to monograph OTCs.

The agency’s document submitted to Congress as justification for its FY 2021 budget request includes in its list of legislative...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Legislation

Stopgap Spending Bill Provides Platform To Plug Gaps In FDA’s OTC Monograph, Switch Pathways

 
• By Malcolm Spicer

OMUFA reauthorization and directions for FDA to provide reports on monograph program and guidance on improving chances for OTC switch applications included in recent stopgap spending bill to end federal government shutdown.

Senate’s Proposed Agreement To End US Shutdown Would Cut FDA Non-User Fee Funding

 
• By Derrick Gingery

But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.

Combat Meth Act PSE Daily Purchase Limit Once Too High For States Now Embraced By Most

 
• By Malcolm Spicer

Limits so effective that states are relaxing restrictions they previously set exceeding the nationwide limit Congress imposed in Combat Meth Act in 2006 on the amount of PSE, as well as a second meth precursor, ephedrine, in OTC drugs consumers can purchase daily.

Senate HELP Committee Adds Sunscreen Regulation Overhaul To OMUFA Reauthorization

 
• By Lauren Nardella

OMUFA reauthorization bill including amendment with sunscreen regulation provisions passed by Senate committee, which also approved other provisions not included in House OMUFA bill.

More from Policy & Regulation

Stopgap Spending Bill Provides Platform To Plug Gaps In FDA’s OTC Monograph, Switch Pathways

 
• By Malcolm Spicer

OMUFA reauthorization and directions for FDA to provide reports on monograph program and guidance on improving chances for OTC switch applications included in recent stopgap spending bill to end federal government shutdown.

Bayer: Product Launches Alone ‘Not Enough’ To Meet Women’s Health Needs

 
• By David Ridley

“It’s not good enough just to provide products anymore, we need to create a service and a holistic approach to products,” argued Bayer Consumer Health's Northern Europe general manager, Mike Knowland, speaking at a recent panel event in the UK Parliament.

BMJ Study: No Clear Link Between In Utero Paracetamol Exposure And Autism, ADHD

 
• By David Ridley

The studies reviewed by BMJ researchers failed to account for the fact that the association between in utero exposure to paracetamol and autism and ADHD in childhood “might be driven by familial genetic and environmental factors.”