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MDUFA IV (And More) Is Law: Trump Signs A Health-Care Bill

Executive Summary

President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.

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Sen. Warren, FDA Commissioner Califf Visit Pharmacy In OTC Hearing Aid Launch

Massachusetts Democrat and FDA commissioner downplay bumps on road to making some hearing aids available OTC. 

Warren, Becerra And Califf Visit Walgreens In OTC Hearing Aid Launch

The Massachusetts Senator, HHS secretary and FDA commissioner held a drug store event to mark the new availability of hearing aids without a prescription. 

Loud And Clear Need In US For OTC Hearing Aids For Mild To Moderate Loss, Congress Tells FDA

Hearing loss is one of the most common conditions affecting older US consumers, with nearly one in three between the ages of 65 and 74 having difficulty hearing, Sens. Warren and Grassley and Resp. Kennedy and Carter note in urging FDA to finalize regulations allowing certain hearing aids to be sold OTC.

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