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'Real Challenge' To Improve OTC Monograph Program Without User Fees – FDA

 
• By Malcolm Spicer

FDA is weighing the potential benefits of, and drawbacks to, establishing user fees to support its OTC drug monograph program, opening a docket for comments and conducting a June 10 public meeting on the subject. Industry seems far from on board at present, and FDA also acknowledges that there could be downsides to a user fee program in addition to potential benefits for companies and consumers.

Industry has reservations about possible user fees to support FDA's OTC drug monograph activities, but the agency is fairly adamant that the program needs greater funding, particularly if it moves forward with a potential overhaul of the system to improve its functioning.

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More from Regulation

US FDA Finds Banned Cosmetic Ingredient Methylene Chloride In Gel Polish Removers

 
• By Lauren Nardella

Testing conducted by the US Food and Drug Administration has found several cosmetic products on the market that contain high levels of methylene chloride, a banned ingredient.

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

 
• By David Ridley

Engaging with EU member state legislators, stressing the impact of national EPR systems on the accessibility, availability, and affordability of medicines, reformulating products to reduce their financial contribution, and lobbying for expanding the scope of EPR schemes to include other polluting industries are all ways that the European consumer health industry can try and influence the way that the revised Urban Wastewater Treatment Directive is transposed into national legislation, law firm Mason Hayes & Curran explains.

French Agency Proposes Effective EU Ban On CBD In Foods And Cosmetics

 
• By David Ridley

France's food safety regulator ANSES is proposing a reproductive toxicity category 1B classification for CBD under the EU's CLP regulation, which would mean an effective ban on CBD in cosmetics and foods. However, French hemp industry association UIVEC hopes that new evidence coming out of a European Commission review will put the issue to bed before it gets that far.

European Commission’s Omnibus VII Bans Two Nail Care Ingredients Starting In September

 
• By Eileen Francis

Two nail care ingredients included in the European Commission’s Omnibus VII, which includes about two dozen ingredients overall, are banned in Europe in September.

More from Policy & Regulation

US FDA Layoffs Expected To Have Ripple Effect On Cosmetics Office Functions

 
• By Lauren Nardella

Functions supporting the US Food and Drug Administration’s Office of Cosmetics and Colors have been impacted by the reduction-in-force.

European Commission’s Omnibus VII Bans Two Nail Care Ingredients Starting In September

 
• By Eileen Francis

Two nail care ingredients included in the European Commission’s Omnibus VII, which includes about two dozen ingredients overall, are banned in Europe in September.

Cosmetics Europe Argues Against Potential Ban Of Common Fragrance, Cosmetic Ingredient Ethanol

 
• By Eileen Francis

Cosmetics Europe is working to obtain derogations for three fragrance and/or cosmetic substances that may be categorized as carcinogenic, mutagenic or reprotoxic, which could result in a ban of their use under the Cosmetic Products Regulation.