Department of Health and Human Services February 2019 – Federal Register Recent Federal Regulation Documents
Results 501 - 550 of 650
Fiscal Year 2019 Generic Drug Regulatory Science Initiatives; Public Workshop; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``FY 2019 Generic Drug Regulatory Science Initiatives.'' The purpose of the public workshop is to provide an overview of the status of regulatory science initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholdersindustry, academia, patient advocates, professional societies, and other interested partiesas it fulfills its commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its fiscal year (FY) 2020 regulatory science initiatives.
Final Guidance Publications for Skin Notation Profiles
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following 5 Skin Notation Profiles [DHHS (NIOSH) Publication No. 2019-117 to 2019-121]:
Final National Occupational Research Agenda for Respiratory Health
NIOSH announces the availability of the final National Occupational Research Agenda for Respiratory Health.
Draft-National Occupational Research Agenda for Hearing Loss Prevention
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft NORA Agenda entitled National Occupational Research Agenda for Hearing Loss Prevention for public comment. To view the notice and related materials, visit https://www.regulations.gov and enter CDC-2019-0001 in the search field and click ``Search.''
Continuing To Protect the Nanotechnology Workforce: NIOSH Nanotechnology Research Plan for 2018-2025
NIOSH announces the availability of Continuing to Protect the Nanotechnology Workforce: NIOSH Nanotechnology Research Plan for 2018- 2015.
The Least Burdensome Provisions: Concept and Principles; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``The Least Burdensome Provisions: Concept and Principles.'' FDA utilizes a least burdensome approach to medical device regulation to eliminate unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval. This document describes the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to products meeting the statutory definition of a device regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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