New Topics Needed for the Secretary's Advisory Committee on Genetics, Health, and Society
Office of the Secretary
In the coming months, the Committee will be identifying new priority issues to address. SACGHS would welcome public perspectives about issues within SACGHS's charter that are in need of attention and study. Members of the public who wish to suggest an issue are asked to submit a statement (approximately one paragraph in length) that (1) Describes a problem or policy challenge that needs exploration and (2) proposes actions the Committee could take to address the issue. Public comments received by May 16, 2008 will be considered by SACGHS and discussed at its meeting on July 7-8, 2008 in Washington, DC.
Submit comments by May 16, 2008 as indicated on the SACGHS website.
Public Comment Needed on NIH Public Access Policy
National Institutes of Health
The National Institutes of Health (NIH) is seeking to engage formally with the broader community on the Public Access Policy in a transparent and participatory manner. The NIH requests input from the community regarding the NIH Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research (NIH Public Access Policy). The NIH Public Access Policy ensures that the public has access to the published results of NIH funded research. It requires scientists to submit journal articles that arise from NIH funds to the digital archive PubMed Central. The Policy requires that these articles be accessible to the public on PubMed Central to help advance science and improve human health.
Submit comments by 5 p.m. EST, May 31, 2008 electronically.
Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan Now Available for Comment
Food and Drug Administration
The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft drug safety 5-year plan entitled "Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan." This plan is intended to communicate FDA's strategy for meeting the commitments for enhancing and modernizing the drug safety system within the context of the PDUFA IV program. At the end of the comment period, FDA will review the comments, update the "PDUFA IV Drug Safety Five-Year Plan," and publish the final version.
Submit electroniccomments using Docket number FDA-2008-N-0257 on the draft drug safety 5-year plan by June 19, 2008.
Public Comment Needed on Healthy People 2020
Department of Health and Human Services
We invite you to give us your comments and suggestions as part of the collaborative process of building Healthy People 2020. You may choose to provide us with feedback on various conceptual aspects and proposals for specific elements, including vision, mission, overarching goals, organizing framework, users, and implementation. Your general comments also are welcome.
Submit comments at any time electronically.
Guidance for Industry on Clinical Trial Endpoints for Approval of Cancer Drugs and Biologics
Food and Drug Administration
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.'' This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in new drug applications, biologics license applications, or supplemental applications. Applicants are encouraged to use this guidance to design cancer clinical trials and to discuss protocols with the agency. This guidance provides background information and discusses general regulatory principles. Additional companion guidances will follow and will focus on endpoints for specific cancer types (e.g., lung cancer, colon cancer) to support drug approval or labeling claims. This guidance, and the subsequent indication-specific guidances, should speed the development and improve the quality of protocols submitted to the agency to support anticancer effectiveness claims.
Submit comments electronically.
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