FDA pressure?

Pharmacists, Deluged With Requirements, Pressure FDA to Standardize REMS Programs.

Pharmacists want the FDA to standardize REMS programs.

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.