This white paper provides a summary of presentations and discussions at a cardiovascular (CV) end point adjudication think tank cosponsored by the Cardiac Safety Research Committee and the US Food and Drug Administration (FDA) that was convened at the FDA's White Oak headquarters on November 6, 2013. Attention was focused on the lack of clarity concerning the need for end point adjudication in ...

And there is more, much more. If the FDA enforces these requirements, drug companies would probably not be sending around dubious articles based on bogus clinical trials, which is Waxman’s concern. The bigger risk is that physicians might not pay close enough attention to the risks of off-label use, which can be substantial. These risks come into play in connection with atypical antipsychotic a...

Oncology nurses and pharmacists often are given the responsibility of developing or updating institutional policies to manage vesicant chemotherapy extravasations. Antidote and treatment recommendations of vesicant chemotherapy manufacturers, antidotes and treatments approved by the U.S. Food and Drug Administration (FDA), and guidelines and recommendations made by professional oncology organiz...

BACKGROUND On June 22, 2009, the US FDA was granted the authority to regulate tobacco products through the Family Smoking Prevention and Tobacco Control Act (FSPTCA). The intent is to improve public health through regulations on tobacco product marketing and tobacco products themselves. This manuscript reports baseline data on smokers' attitudes and beliefs on specific issues relevant to the FS...

OBJECTIVE To evaluate the number and type of warning letters issued by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers for promotional violations. METHODS Two reviewers downloaded, printed and independently evaluated warning letters issued by the FDA to pharmaceutical manufacturers from years 2003-2008. Misleading claims were broadly classified as clinical, Quality-o...

Under the remit of the Ministerial Industry Strategy Group (MISG), the Association of the British Pharmaceutical Industry (ABPI) and Medicines and Healthcare products Regulatory Agency (MHRA) hosted a meeting to explore physiologically based pharmacokinetic modeling and simulation, focusing on the clinical component of regulatory applications. The meeting took place on 30 June 2014 with interna...

Whenwe first published this News story (BMJ 2015;351:h6820, doi:10.1136/bmj.h6820), we reported that Diana Zuckerman, president of the National Center for Health Research, told The BMJ that no more than two dozen non-profit organizations that are members of the Patient, Consumer, and Public Health Coalition had been invited by the FDA to help develop any provisions of the 21st Century Cures Act...

BCECAUSE organizations vary in how they anticipate and respond to ethical problems in the work environment, the 14 October meeting of the AAAS Professional Society Ethics Group focused on how one prominent and highly visible organization-the National Aeronautics and Space Administration (NASA)-incorporates ethical considerations into its planning and decision-making. Representing NASA were John...

FDA's proposed graphic warning labels for cigarette packages have been scrutinized for potentially violating the First Amendment's free speech clause. This article addresses the distinction between the commercial speech and compelled speech doctrines and their applicability in analyzing the constitutionality of the labels. The government's position is that the labels evoke an emotional response...

In response to concerns expressed by applicants regarding inconsistent policies in establishing blend uniformity acceptance criteria to demonstrate adequacy of mix, the FDA Office of Generic Drugs (OGD) issued the draft document Guidance for Industry, ANDAs: Blend Uniformity Analysis (August 1999). Both generic and innovator pharmaceutical companies raised a number of concerns following the pub...