FDA legislation

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

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...

FDA Express

Microring-based photonic fractional differentiators play an important role in the on-chip all-optical signal processing. Unfortunately, the previous works do not consider the time-reversal and the time delay characteristics of the microring-based fractional differentiator. They also do not include the effect of input pulse width on the output. In particular, it cannot explain why the microring-...

23andMe and the FDA.

n engl j med 370;11 nejm.org march 13, 2014 985 of things about your health,” including that you “might have an increased risk of heart disease, arthritis, gallstones, [or] hemochromatosis” (www.ispot.tv/ad/7qoF/ 23-and-me). It was the centerpiece of the company’s campaign to sign up 1 million consumers. On November 22, the Food and Drug Administration (FDA) sent 23andMe a warning letter orderi...

FDA regulatory compliance reconsidered.

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1004 R I. AN INTRODUCTORY WORD, MAINLY CONCERNING SCOPE . . . 1004 R II. FDA REGULATION’S ORIGINS AND DEVELOPMENT. . . . . . . . . . 1007 R III. ANALYSIS OF REGULATORY COMPLIANCE’S RELEVANCE. . . . . . 1010 R A. The Relevance Traditionally Accorded Regulatory Compliance . . . . . . . ....

The FDA and ECT.