European FDA

FDA Reform and the European Medicines Evaluation Agency

FDA assigns drug master file to European cancer group.

Dr. Gregory R. Mundy Texas, San Antonio, but they also decrease the number of tumor cells that are in bone, and "we guess they do that by changing the bone environment and making the bone a less hospitable place for the cancer cells to grow." The majority of breast cancer patients in whom cancer has spread beyond its primary origin experience metastases to bone. For these patients, a loss in bo...

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 . . . . . . . ....