US device industry and FDA "colluded" on legislation to weaken regulatory oversight.

نویسنده

  • Jeanne Lenzer
چکیده

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 or its Senate companion bill. This should have read that Zuckerman told The BMJ that “none of the more than two dozen” non-profit organizations had been invited to help develop provisions of the proposed act. This error was corrected online on 18December 2015.We apologise for this error.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Digital Direct-to-Consumer Advertising: A Perfect Storm of Rapid Evolution and Stagnant Regulation; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

The adoption and use of digital forms of direct-to-consumer advertising (also known as “eDTCA”) is on the rise. At the same time, the universe of eDTCA is expanding, as technology on Internet-based platforms continues to evolve, from static websites, to social media, and nearly ubiquitous use of mobile devices. However, little is known about how this unique form of pharmaceutical marketing impa...

متن کامل

The FDA and genetic testing: improper tools for a difficult problem

The US Food and Drug Administration (FDA) has recently issued draft guidance on how it intends to regulate laboratory-developed tests, including genetic tests. This article argues that genetic tests differ from traditional targets of FDA regulation in both product as well as industry landscape, and that the FDA's traditional tools are ill-suited for regulating this space. While existing regulat...

متن کامل

Health Policy and Cardiovascular Medicine

1136 The US Food and Drug Administration (FDA) is among the oldest agencies in the federal government. Its origins can be traced back to 1862, when President Abraham Lincoln appointed a chemist, Charles M. Wetherill, to serve in the Department of Agriculture. One of the key early pieces of legislation that initiated the evolution of the FDA into its modern form was the 1906 Pure Food and Drug A...

متن کامل

Update on medical and regulatory issues pertaining to compounded and FDA-approved drugs, including hormone therapy

OBJECTIVE We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone therapies (CBHTs), which do not have proper labeling and warnings, and anticipated impact of the 2013 Drug Quality and Security Act (DQSA) on compounding. METHODS US government websites were searched for documents co...

متن کامل

The Tip of the Iceberg of Misleading Online Advertising; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

Kim’s overview of Food and Drug Administration (FDA) regulatory actions from 2005 to 2014 is a comprehensive analysis of the US regulatory experience with online direct-to-consumer advertising (DTCA) of prescription medicines. This experience is of relevance internationally as online DTCA reaches the English-speaking public globally, despite the illegality of DTCA in most countries. The most co...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:
  • BMJ

دوره 351  شماره 

صفحات  -

تاریخ انتشار 2015