FDA seeks feedback at 13 June virtual hearing on three general topics related to advisory committees: panel composition, barriers to service for Special Government Employees, and public perception and understanding of the process.
The US Food and Drug Administration’s initiative to optimize the advisory committee process is going out for public comment, suggesting that despite ongoing reform efforts, major changes may not be implemented for some time.
The FDA will hold a virtual listening session on 13 June to solicit feedback on the agency’s use and processes...
The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”
If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos
HBW Insight speaks to NèreS' executive director Luc Besançon about the key issues facing France's self-care industry, especially Rx-to-OTC switch and the revised Urban Wastewater Treatment Directive.
Effective date for ACNU OTC switch final rule and finding of severe itching from long-term use of common allergy ingredients are bookends for limits of FDA’s authority for product label changes.
Market growth and product innovations are continuing as FDA looks to Congress for authorization to establish regulatory pathway agency says it needs to determine whether to allow hemp-derived ingredients in food, dietary supplements and non-drug topicals including cosmetics.
Consumer health player PharmaSGP will be taken private by its biggest shareholder, FUTRUE.
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
