Department of Health and Human Services October 6, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
Common Formats for Reporting on Health Care Quality and Patient Safety
As authorized by the Secretary of HHS, AHRQ coordinates the development of sets of common definitions and reporting formats (Common Formats) for reporting on health care quality and patient safety. The purpose of this notice is to announce the availability of two new sets of Common Formats for public review and comment: 1) Common Formats for retail pharmaciesCommon Formats for Retail Pharmacy; and 2) the healthcare associated infection (HAI) module for Common Formats for Surveillance.
Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Generic Drug User Fee Cover Sheet
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.
Established Conditions: Reportable Chemistry, Manufacturing, and Controls Changes for Approved Drug and Biologic Products; Draft Guidance for Industry; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for the ``Established Conditions: Reportable Chemistry, Manufacturing, and Controls (CMC) Changes for Approved Drug and Biologic Products; Draft Guidance for Industry,'' published in the Federal Register of June 1, 2015. FDA is reopening the comment period to allow interested persons additional time to submit comments.
Electronic Common Technical Document Technical Conformance Guide; Availability
The Food and Drug Administration (FDA) is announcing the availability of an Electronic Common Technical Document (eCTD) Technical Conformance Guide, Version 1.0. The eCTD Technical Conformance Guide supplements the guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatCertain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specification'' and provides specifications, recommendations, and general considerations on how to submit eCTD-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Acceptability of Draft Labeling To Support Abbreviated New Drug Application Approval; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Acceptability of Draft Labeling to Support ANDA Approval.'' This guidance provides recommendations and information related to the submission of proposed labeling with abbreviated new drug applications (ANDAs). It explains FDA's interpretation of the regulatory provision related to submission of copies of applicants' proposed labeling and clarifies that FDA's Office of Generic Drugs (OGD) will accept draft labeling and does not require the submission of final printed labeling (FPL) in order to approve an ANDA.
Electronic Submission of Final Approved Risk Evaluation and Mitigation Strategies and Summary Information in a Standard Structured Product Labeling Format; Pilot Project
The Food and Drug Administration (FDA or Agency) is announcing a pilot project for the submission of final approved Risk Evaluation and Mitigation Strategies (REMS) and certain REMS summary information electronically in a standard Structured Product Labeling (SPL) format. Participation in the pilot is voluntary and is open to application holders of drugs with REMS. The pilot is intended to help application holders, FDA, and other interested stakeholders evaluate a potential approach to converting REMS into SPL format and evaluate the usefulness of the REMS information to be provided in SPL format. This project also will help provide FDA with feedback on these topics from pilot participants and other interested stakeholders.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
