Tag Archives: FDA

Inside (the Beltway) Scoop

Congress to Begin Work on Fiscal Year 2017 Spending Bills in April; Senate Committee Continues To Make Progress on Medical Innovation Legislation Capitol Hill will be quiet for the next two weeks as members of Congress observe spring break ahead of what is expected to be a busy period of legislative activity over the next… Read More »

FASEB questions utility of FDA pilot program

In response to a request from the Food and Drug Administration (FDA), the Federation of American Societies for Experimental Biology (FASEB) submitted comments questioning the usefulness of the pilot Clinical Outcome Assessment Compendium (COAC) on March 2. Intended to provide clarity to researchers designing clinical trials or developing new drugs, the COAC combines metrics for… Read More »

FASEB Comments on Clinical Data Proposals

On August 5, the Federation of American Societies for Experimental Biology (FASEB) issued recommendations on two proposals regarding clinical data. FASEB commented on an approach under consideration at the Food and Drug Administration (FDA) to collect healthcare and clinical research information from common participants and a request for information on maintaining the registry and results… Read More »

FASEB Comments on Challenges to NIH in Letter to Senate HELP Committee

In January 2015, the Senate Health, Education, Labor, and Pensions (HELP) Committee released a white paper, Innovation for Healthier Americans, outlining challenges faced by the National Institutes of Health (NIH) and the Food and Drug Administration that contribute to inefficiencies in the delivery systems for drug and medical products. The HELP Committee asked for feedback… Read More »

FASEB Outlines Concerns on Proposed Changes to Reporting of Clinical Trial Information

In comments on proposed changes governing the registration and reporting of clinical trial results, the Federation of American Societies for Experimental Biology (FASEB) noted the importance of having standardized, transparent, and publicly available information about clinical trials available to avoid unintended duplication of studies and detect adverse events. FASEB also raised concerns about certain aspects… Read More »

FDA Seeks Input on Regulation of Next Generation DNA Sequencing Technologies

The Food and Drug Administration (FDA) recently held a workshop to discuss the state of human genetics and genomics testing using next generation sequencing (NGS) technologies. The agency also sought feedback from stakeholders on its proposed approach to regulate NGS diagnostic tests. NGS refers to a collection of new technologies that, together, enable rapid sequencing… Read More »

Inside (the Beltway) Scoop

President Sends Budget Request to Congress; Appropriations Committees Announce Deadlines for Fiscal Year 2016 Requests; Bills Introduced to Increase Funding for Biomedical Research President Barack Obama released his fiscal year FY 2016 budget on February 2, providing more detail about the proposals he outlined in his State of the Union speech. The president proposed a… Read More »