Department of Health and Human Services February 26, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 7 of 7
Notice of Opportunity To Co-Sponsor OMH National Minority Health Month Steps Challenge
OMH announces the opportunity for public and non-profit entities to co-sponsor the National Minority Health Month National Steps Challenge for April 2019. Potential co-sponsors must have a demonstrated interest in reducing health disparities among minority communities, advancing the HHS Physical Activity Guidelines and improving the health of Americans through promoting regular physical activity.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Supplier Verification Programs for Food Importers
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Assessing the Effects of Food on Drugs in Investigational New Drug Applications and New Drug Applications-Clinical Pharmacology Considerations; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing the Effects of Food on Drugs in INDs and NDAsClinical Pharmacology Considerations.'' This draft guidance provides recommendations to sponsors planning to conduct food-effect trials for orally administered products as part of investigational new drug applications (INDs), new drug applications (NDAs), and supplements to these applications. This draft guidance, when final, revises and replaces part of the 2002 FDA guidance for industry entitled ``Food-Effect Bioavailability and Fed Bioequivalence Studies'' (2002 Food Effect Guidance).
Bioavailability Studies Submitted in New Drug Applications or Investigational New Drug Applications-General Considerations; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bioavailability Studies Submitted in NDAs or INDsGeneral Considerations.'' This draft guidance provides recommendations to sponsors planning to include bioavailability (BA) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. This draft guidance revises and replaces FDA's March 2014 draft guidance for industry entitled ``Bioavailability and Bioequivalence Studies Submitted in NDAs or INDsGeneral Considerations,'' which addresses BA or bioequivalence (BE) studies for INDs, NDAs, and NDA supplements.
Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments; Reopening of Comment Period
The Food and Drug Administration (FDA or Agency) is reopening the comment period for the notice entitled ``Prescription Drug-Use- Related Software; Establishment of a Public Docket; Request for Comments'' that appeared in the Federal Register of November 20, 2018. The Agency is taking this action to allow interested persons additional time to submit comments.
Sunscreen Drug Products for Over-the-Counter Human Use
The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. This proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. It is being published as part of the ongoing review of OTC drug products conducted by FDA. It is also being published to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Sunscreen Innovation Act (SIA).
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