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Current Fetal Ultrasound Practices Could Increase Risks, Studies Suggest

This article was originally published in The Gray Sheet

Executive Summary

A sharp increase in the use of fetal ultrasounds in recent years in women with healthy pregnancies from an average of 2 scans to 5 scans per pregnancy and recent warnings from medical societies could prompt FDA to look more closely at possible risks to the fetus from ultrasound.

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An ultrasound manufacturer no longer needs to submit a "510(k) special report" prior to shipping a new device as long as it keeps appropriate records in its design history file, according to an FDA 1guidance issued Sept. 9

Big Pharma CEOs Suggest Policy Changes As They Return To Beijing

Global CEOs of J&J, Pfizer, AbbVie and Takeda were among the top pharma executives attending the China Development Forum in its first in-person meeting in three years, and highlighted a number of pharma-related policy changes they would like to see in China. Meanwhile, a Japanese employee of Astellas has been detained in the country for alleged espionage.


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