News & Analysis as of

Zika Food and Drug Administration (FDA)

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Approves Release of Genetically Engineered Mosquitoes

Lost among reports of the first locally transmitted cases of the Zika virus in the continental United States in late July (as well as concern over Zika transmission at the 2016 Summer Olympics in Rio de Janeiro, Brazil in...more

Bergeson & Campbell, P.C.

Florida House Members Request Emergency Authorization to Combat Aedes aegypti Mosquitoes with Oxitec

On September 6, 2016, 61 members of the Florida House of Representatives issued a letter to the U.S. Department of Health and Human Services (HHS) and to the U.S. Food and Drug Administration (FDA) to urge them to: (1)...more

BakerHostetler

Capitol Hill Healthcare Update

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House Energy and Commerce Committee Chairman Fred Upton (R-MI) acknowledged publicly last week what has been widely suspected on Capitol Hill – his “21st Century Cures” medical innovation legislation will not pass Congress...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: Double Issue — Congress leaves for seven weeks, Congress sends opioid legislation to the President…More co-ops fail…The Supreme Court rules on Texas Abortion Case and Washington state Pharmacists and Religious...more

Knobbe Martens

FDA grants Emergency Use Authorization to Quest Diagnostics for Zika Test

Knobbe Martens on

According to Medical Device Daily, the US Food and Drug Administration (FDA) has authorized the emergency use of a diagnostic molecular test developed by Quest Diagnostics subsidiary, Focus Diagnostics Inc., in response to...more

Baker Donelson

Washington, D.C. Update – April 2016

Baker Donelson on

FY17 Appropriations - The House and Senate Appropriations Committees continue to move forward on individual FY17 spending measures based on discretionary spending levels enshrined in last fall's bipartisan budget deal....more

Morgan Lewis

FDA Active on the Device Front for Q1 2016

Morgan Lewis on

Additional guidance documents are expected. The US Food and Drug Administration’s (FDA’s) first quarter of calendar-year 2016 has been a busy one on the medical device front. FDA’s Center for Devices and Radiological...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: Medicaid program takes financial hits as the House looks for “savers” and acts on a budget... while the Senate sees no reason to do a budget... The Senate focuses on ACA oversight and mental health and opioid abuse...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: The House and Senate were out for Presidents’ Day recess... The Senate to vote on FDA Commissioner nominee Califf after 5:30 today... Medicare Advantage rates announced....more

Mintz - ML Strategies

Health Care Update - February 2016 #3

Mintz - ML Strategies on

The Administration is Ramping Up Drug Pricing Response - The President’s budget makes clear for all to see that the Administration wants to do something related to drug pricing. Unfortunately for the Administration,...more

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