Regulation/Legislation (Health)
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Regulation
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Latest From Health & Regulation
Longer Exclusivity Periods For EU Centralized Rx-To-OTC Switches? Commission Says No
One way to revitalize interest in the EU's centralized switch procedure would be to introduce longer data exclusivity periods or market exclusivity for successful applicants, concluded an AESGP expert switch panel presenting at the association's 59th Annual Meeting in Paris, France. However, a European Commission representative told another panel that this was not under consideration as part of the EU pharmaceutical legislation revision.
Pending Decision On First US OTC Birth Control Shines Spotlight On Self-Report Study Data
Approval likely would account for all weight on scale of FDA decision if not for self-report element in design of HRA Pharma’s actual use study for OTC switch of 0.075-mg norgestrel branded Opill. HRA’s sNDA offers lesson for using electronic diary apps in self-report studies.
AESGP Annual Meeting: OTC Antifungals, Antivirals Could Become Rx In EU
The European Commission shocked participants at this year's AESGP Annual Meeting by warning that OTC antifungals, like treatments for athlete’s foot, and OTC antivirals, like cold sore creams, could soon become prescription-only within the region, under proposed revisions to the EU pharma legislation. There is hope, however. The proposals are still open to feedback from industry, the AESGP points out, and even if this proposal becomes law, member states can waive this prescription requirement under certain conditions.
Legislation
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Latest From Health & Legislation
Longer Exclusivity Periods For EU Centralized Rx-To-OTC Switches? Commission Says No
One way to revitalize interest in the EU's centralized switch procedure would be to introduce longer data exclusivity periods or market exclusivity for successful applicants, concluded an AESGP expert switch panel presenting at the association's 59th Annual Meeting in Paris, France. However, a European Commission representative told another panel that this was not under consideration as part of the EU pharmaceutical legislation revision.
What Would US FDA Do If Supreme Court Eliminates Or Curtails Chevron Deference?
Lawyers say agency will have to bolster its administrative record as judges tackle complex policy and scientific issues previously left to FDA. Some cases, such as challenges to exclusivity decisions, may be reopened.
House Appropriations Subcommittee Proposes FDA FY2024 Budget $662M Short Of Request
Appropriations Agriculture, Rural Development, FDA and Related Agencies Subcommittee marked up its FY2024 bill on 18 May, proposing $6.579bn for FDA. Total is up from current budget of $6.562bn, but Biden administration proposed $7.2bn for FY2024.
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