The National Institutes of Health has released a proposed rule designed to provide clarity on the requirements surrounding the submission of information to ClinicalTrials.gov, as mandated by the Food and Drug Administration Amendments Act of 2007. Among these requirements is the submission of summary results for clinical trials involving all pharmaceuticals, medical devices and biological products, regardless of whether they have been approved, licensed or cleared by the Food and Drug Administration. The rule also provides timetable restrictions for the registration of a clinical trial and submission of summary results, as well as guidelines for the reporting of adverse events.… Continue Reading
The FDA recently released draft guidance designed to accelerate the development and review process for drugs intended to treat Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME), a condition for which there is currently no FDA-approved treatment. Though non-binding, the guidance should help drug manufacturers design and execute studies that are more likely to succeed in satisfying the FDA clearance requirements that there be "substantial evidence" of the efficacy of a product and an acceptable risk/benefit profile. The guidance will become finalized following the end of its notice/comment period on May 12, 2014.… Continue Reading
On September 26, 2011, the U.S. Department of Health and Human Services (“HHS”) issued new regulations governing the disclosure by faculty members and research staff of significant financial interests related to certain federal grants, and the reporting of “financial conflicts of interest” to certain federal agencies by colleges and universities that receive funding for Public … Continue Reading
In an article entitled, "The Legal Duties Of Clinical Trial Sponsors," published by Law360.com on July 11, 2011, Reed Smith attorney Kevin Lohman addresses the risks involved in human clinical trials and the responsibilities between the clinical study investigator and the manufacturer/sponsor.… Continue Reading
On January 13, 2009, the FDA published a notice seeking comments on issues related to the enrollment of certain populations in clinical drug trials. This request is related to FDA’s implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA) section 901, which requires the FDA to report to Congress on best practice approaches … Continue Reading
The FDA has released final guidance on “Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007.” The guidance describes the FDA’s current thinking regarding the types of applications and submissions that sponsors, … Continue Reading
A lesser-known provision in the Medicare Program allows payment for “reasonable and necessary” items or services provided through clinical trials. At the same time, even for traditional reimbursement, the Centers for Medicare & Medicaid Services (CMS) increasingly is demanding evidence of effectiveness in the Medicare population, rather than simply in the general population, to support a … Continue Reading
