VIDEO. Click on title to see video. Senator Elizabeth Warren spoke about her concerns with the 21st Century Cures Act on the Senate floor on November 28, 2016.
Biosimilar trials differ notably from innovator studies
www.appliedclinicaltrialsonline.com
Some type of clinical testing is expected at this point to gain market approval for most biosimilars. Large comparative clinical trials defeat the purpose of the abbreviated development program for biosimilars, according to FDA officials, and studies that merely replicate the safety and efficacy findings of the innovator product risk raising costs and delaying patient access to an alternative therapy. Instead, the biosimilar pathway permits licensure based on less than full clinical data, and is based on significant differences in developing biosimilars and innovator therapies (Applied Clinical Trials Online)
Sharp decline in new drug approvals at FDA this year
PODCAST
Bloomberg’s Jeannie Baumann joins Nancy Lyons in the Bloomberg Washington newsroom to discuss why the FDA has approved less than half the number of new drugs this year as it has in previous years. (Bloomberg)
FDA issues Guidance on the use of non-inferiority trials to establish effectiveness
The FDA recently finalized guidance on the appropriate use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or biologic, usually because a superiority study design cannot be used. The guidance gives advice on when NI studies intended to demonstrate effectiveness of an investigational drug can provide interpretable results, how to choose the NI margin, and how to test the NI hypothesis. (Regulatory Affairs Professional Society)
Biocom program “Zika Virus and Emerging Diseases” highlights importance of public-private collaboration
by Marie Jung BioCom’s October 13th Breakfast Meeting on “Zika Virus and Emerging Diseases” was not one to be missed, but in case you had something else going on, Clinical Currents is here to update you. The talk was sponsored by DLA Piper, and was led by Karen Midthun, M.D., Read more
Industry calls for more guidance from FDA on new clinical trials technology
The initiation of a new era of mobile health technology has erupted into industry calling on the US Food and Drug Administration (FDA) to offer more guidance on how best to use new technology, like Fitbits and mobile apps, in clinical trials, and to find ways that don’t restrict the development of novel tech products. (raps.org)
EHR Data in Clinical Trials: New FDA Draft Guidance
The US Food and Drug Administration (FDA) on Monday released draft guidance to assist clinical trial sponsors, investigators, contract research organizations (CROs), institutional review boards (IRBs) and other using electronic health record (EHR) data in FDA-regulated clinical investigations. The 12-page guidance is meant to facilitate the use of EHR data in clinical trials and “promote the interoperability of EHRs and electronic systems supporting such trials.” (raps.org)
FTC releases new tool for developers of mobile health apps
The Federal Trade Commission has created a new web-based tool for developers of health-related mobile apps, which is designed to help the developers understand what federal laws and regulations might apply to their apps. The FTC developed the tool in conjunction with the Department of Health and Human Services’ Office of National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR) and the Food and Drug Administration (FDA). (ftc.gov)
RAPS seeks writers for regulatory writing book
If you or a colleague have expertise in any of the available topics and would be interested in sharing that knowledge, please contact Senior Editor Pam Jones at pjones@raps.org with the specific topic and a CV.
FDA issues draft guidance for notifying the public of emerging postmarket medical device signals
The Food and Drug Administration (FDA) is issuing this draft guidance to describe the Agency’s policy for notifying the public about medical device “emerging signals.” For the purposes of this guidance, an emerging signal is new information about a medical device used in clinical practice…
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