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The American Medical Association (AMA) last week approved a proposal calling for HHS to establish a comprehensive registry for clinical trials conducted in the U.S. to ensure that all study results — positive and negative — are publicly available.
To help expedite the drug approval process, the FDA is stepping up its efforts to get pharmaceutical companies to submit more complete applications for new molecular entities (NMEs).
The FDA appears to have leaned on one of its scientists to present unreliable and misleading data about a possible link between antidepressant use and suicide in children, according to a June 16 letter from the Senate Finance Committee chairman to HHS Secretary Tommy Thompson.
The FDA yesterday released three final guidances to help firms prepare and submit applications for medical imaging drugs and biological products -- agents that are used solely to diagnose and monitor diseases or conditions rather than to treat them.
Beginning with today's issue, your FDAnews publication will be delivered to you in a new, interactive PDF format designed to eliminate the need for scrolling through the document to find a story or to read the continuation of an article.
The FDA reported progress on several key electronic data initiatives under the purview of the International Conference on Harmonisation (ICH) at a May public meeting.
Configuration management (CM) tools can greatly enhance a company’s Part 11 compliance efforts, but finding the right solution among the array of available products on the market can be challenging.
The FDA this month extended from the end of the year to mid-2005 the deadline for pharmaceutical companies to begin submitting product labeling using the new structured product labeling (SPL) standard.
Recent events have yielded mixed results for life science companies trying to understand or track key technology regulations and standards, including the progress of electronic health initiatives coming out of the FDA. For example, the future of CFR 21 Part 11 — the agency’s regulations covering electronic records and electronic signatures — was left up in the air when the agency decided to not reschedule a June 11 meeting on the regulation, which had been cancelled as part of a national day of mourning for former President Ronald Reagan. The agency did hold a public meeting on the structured product labeling (SPL) standard in June and unveiled a new implementation timetable that gives industry more time to transition to the new specification for submitting drug labeling information electronically. The FDA also provided an update of key International Conference on Harmonisation initiatives, including the electronic common technical document, and HHS named a new IT czar and touted progress on ehealth records.
The implementation timeline for the new FDA gateway for electronic submissions has been delayed by “contracting issues,” said Michael Fauntleroy, program manager at the FDA Gateway program and director of the electronic submissions program at the Center for Biologics Evaluation and Research (CBER).