FDA’s Rulemaking To-Do List Includes Clarifying Citizen Petitions And Orphan Drug Designations
FDA pending actions include proposed rules on the handling of citizen petitions, eligibility for orphan drug designation and post-market safety reporting for combination products.
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Drug Shortage Rules Surface In Latest FDA Regulatory Agenda
FDA has yet to prognosticate on a schedule for other FDASIA-mandated regulations; HHS says that FDA’s priorities for the coming year will involve devices and food, as well as promoting international regulatory cooperation.
Drug Sample Distribution Reporting Deadline Extended By FDA
FDA is giving manufacturers six more months to provide HHS with information on the distribution of drug samples as it plans further guidance; the Affordable Care Act mandated that the data be submitted by April 1.
Orphan Disclosures Could Increase Under Tweaks Proposed By FDA
Agency considering whether to tell public if sponsors have submitted annual product development reports as part of proposed rule clarifying portions of 1992 Orphan Drug Regulations.