Department of Health and Human Services July 14, 2009 – Federal Register Recent Federal Regulation Documents
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Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.'' This document provides guidance to industry on postmarketing serious adverse event reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application. It gives guidance on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports. Separate guidance, issued by FDA's Center for Food Safety and Applied Nutrition on adverse event reporting for dietary supplements, is announced elsewhere in this issue of the Federal Register.
Guidance for Institutional Review Boards, Frequently Asked Questions-Institutional Review Board Registration; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Institutional Review Boards (IRBs), Frequently Asked Questions IRB Registration.'' This guidance is intended to assist IRBs in complying with the new requirement for IRB registration. This new rule requires each IRB in the United States that reviews FDA-regulated research to register using an Internet-based registration system that is maintained by the Department of Health and Human Services (HHS). This registration system is a modification of the one currently used by the Office for Human Research Protections (OHRP) for registration of IRBs that are designated by institutions under Federalwide Assurances (FWAs). OHRP has issued a similar rule requiring IRBs designated by institutions under FWAs to register or update their registration information using this modified system.
Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' The document provides guidance to the dietary supplement industry for complying with the serious adverse event reporting and recordkeeping requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). Separate guidance, issued by FDA's Center for Drug Evaluation and Research, on reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application, is announced elsewhere in this issue of the Federal Register.
Dual Antiplatelet Therapy Trial: Research Project Grant (R01)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Office of Critical Path Programs (OCPP). The goal of the Dual Antiplatelet Therapy (DAPT) Trial is to solicit a sole source grant application from Harvard Clinical Research Institute (HCRI) that proposes to provide funding in support of a dual antiplatelet therapy clinical trial being conducted by HCRI.
Draft Guidance for Industry on “Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting,” Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting.'' This draft guidance provides recommendations to pharmaceutical manufacturers on design considerations for incorporating physical-chemical identifiers (PCIDs) into solid oral dosage forms (SODFs), supporting documentation to be submitted in new drug applications (NDAs) and abbreviated new drug
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection under the project: ``Evaluation of AHRQ's Effective Health Care Program.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
Agency for Healthcare Research and Quality
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component through 2012.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
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