FDA determines BILTRICIDE (praziquantel) 600mg oral tablets were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions meeting regulatory requirements.
HRSA's AIDS Drug Assistance Program data reporting collection (OMB No. 0915-0345) is under OMB review with a 30-day public comment period before approval.
CMS is soliciting public comments for 60 days on proposed information collection activities under the Paperwork Reduction Act of 1995.
Center for Scientific Review holds closed National Institutes of Health peer review meetings on specified dates to evaluate research grant applications across multiple scientific disciplines.
FDA seeks 60-day public comment on information collection requirements for premarket approval of medical devices under the Paperwork Reduction Act.
Center for Scientific Review holds closed meetings to review National Institutes of Health grant applications across biomedical and behavioral research disciplines.
National Institutes of Health Director's office holds a public meeting to discuss agency policies and research funding priorities.
CMS is seeking public comment on proposed information collection activities under the Paperwork Reduction Act; the 60-day comment period allows stakeholders to address burden estimates and collection methodology.
FDA is withdrawing approval of GlaxoSmithKline's Wellcovorin (leucovorin calcium) tablets in 5 mg and 25 mg strengths due to the applicant's request following market discontinuation.
FDA requests 60-day public comment on information collection requirements for food and color additive petitions, master file submissions, and Form FDA 3503 electronic filings.
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