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The United States Food and Drug Administration Patient Protection and Affordable Care Act (PPACA)

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -

Healthcare Weekly Preview from ML Strategies – June 2017 #3

Welcome back everybody. In general, this week insurers will submit their applications for participating in the Marketplace for 2018. After this we will begin to find out where the insurance deserts are and how much rates will...more

Capitol Hill Healthcare Update

by BakerHostetler on

With only 10 legislative days before Senate Republicans’ self-imposed deadline, GOP lawmakers face growing obstacles in their quest to vote on replacing the Affordable Care Act (ACA) before the beginning of their scheduled...more

Capitol Hill Healthcare Update

by BakerHostetler on

Senate Republicans continue intra-party discussions on changes to House-passed legislation replacing the Affordable Care Act (ACA), but the lack of consensus is threatening GOP leaders’ pledge to have a bill ready for a vote...more

Capitol Hill Healthcare Update

by BakerHostetler on

Senate Republicans return to Washington this week after a 10-day recess facing a key inflection point in their effort to repeal and replace the Affordable Care Act (ACA) as GOP leaders will outline policy options they hope...more

Congress Returns for June Session to Face AHCA, User Fees and More

Congress returns from its Memorial Day recess to four full weeks of legislative activity. The drama of the American Health Care Act (AHCA) now hangs over the Senate. The House will return to its regular work once they advance...more

What’s New in Washington: 10 Things You Need to Know

Despite the headlines coming out of Washington, Congress continues to move forward in regular fashion, discussing and acting upon key issues, such as funding the government, addressing the need to raise the debt ceiling and...more

President Trump’s Proposed FY 2018 Budget Spares Medicare, But Calls for Deep Medicaid Cuts & FDA User Fee Hikes

by Reed Smith on

President Trump has released his FY 2018 budget proposal, which the Administration dubs “A New Foundation for American Greatness.” The proposed budget – which received a generally chilly reception on Capitol Hill – offers a...more

Trump Administration Releases Fiscal Year 2018 Budget Proposal

by Baker Donelson on

On Tuesday, May 23, the White House released the President's fiscal year 2018 (FY18) budget, launching a contentious and consequential debate that is expected to last through the end of the fiscal year and possibly beyond....more

Trump Administration FY 2018 Budget and Healthcare Programs

by Holland & Knight LLP on

The Trump Administration released on May 23, 2017, its full Fiscal Year (FY) 2018 budget request, titled "A New Foundation for American Greatness." President Donald Trump's request builds off of the administration's March 16...more

Health Update - May 2017

Mapping the Healthcare M&A Landscape Under the New Administration - Editor’s Note: The healthcare M&A market continues to be among the most active sectors. In a recent webinar, Manatt examined how the policies and goals of...more

Outlook 2017 Teleconference: Revisiting the Trump Administration’s Impact on Life Sciences and Health Care—the First 100 Days

by Ropes & Gray LLP on

On Tuesday, May 2, Ropes & Gray hosted a teleconference, “Outlook 2017 Teleconference: Revisiting the Trump Administration’s Impact on Life Sciences and Health Care – the First 100 Days,” on the potential regulatory and...more

Health Care Weekly Preview from ML Strategies – May 2017

We are half way through May – are we having fun yet? There is a lot of activity this week in addition to ongoing talks in the Senate regarding their version of the American Health Care Act. The reauthorization of FDA User...more

Capitol Hill Healthcare Update

by BakerHostetler on

Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee, teeing up approval by the full Senate, likely after...more

100 Days Plus Under Trump: What They Mean for Biologics

President Donald J. Trump has now been in office for just over one hundred days. Observers have been quick to mark this milestone and assess the new administration’s performance, especially on headline-grabbing issues like...more

FDA’s Delay in Implementing Calorie Labeling Law Leaves Fate Uncertain

by Bryan Cave on

The latest delay by the Food and Drug Administration (FDA) in implementing new calorie labeling rules gives restaurants and food retailers a little breathing room. Originally set for May 5, the agency pushed back the deadline...more

Capitol Hill Healthcare Update

by BakerHostetler on

House approval last week of legislation repealing and replacing most of the Affordable Care Act (ACA) sets up a showdown in the Senate, where GOP leaders will confront a familiar web of political, policy and procedural...more

Capitol Hill Healthcare Update

by BakerHostetler on

Eight weeks after its introduction, legislation to “repeal and replace” the Affordable Care Act (ACA) won House approval today by a 217-213 vote. Vice President Mike Pence on Sunday said a vote in Congress to repeal the ACA...more

Health Care Weekly Preview from ML Strategies – April 2017

Welcome back everybody. While the momentum around an American Health Care Act (AHCA) comeback is unclear, there’s no discounting that efforts are ongoing to reach a consensus among House Republicans with significant pressure...more

Capitol Hill Healthcare Update

by BakerHostetler on

Although House Republicans made progress on bridging ideological differences over how to replace the Affordable Care Act (ACA), GOP leaders say not to expect a vote this week as Congress faces a more immediate deadline: The...more

Capitol Hill Healthcare Update

by BakerHostetler on

House Republicans of all ideological stripes say they are committed to rekindling interest in the American Health Care Act (AHCA), but while the interest is real, so too are the policy and political divisions that thwarted...more

What’s New in Washington: 10 Things You Need to Know

As the Trump presidency completes its first 10 weeks, the administration is celebrating big wins on the regulatory reform front while nursing some wounds from a major defeat on efforts to repeal and replace the Affordable...more

Capitol Hill Healthcare Update

by BakerHostetler on

House Speaker Paul Ryan’s decision to cancel Friday’s vote on the American Health Care Act triggered post-mortem jockeying among vying GOP factions struggling to come to grips with how the party failed to repeal a law it has...more

Capitol Hill Healthcare Update

by BakerHostetler on

House Republicans are scheduled to vote Thursday night on legislation to repeal most of the Affordable Care Act (ACA) even as GOP leaders scramble to secure the final votes needed to pass the bill. House leaders said...more

Food and Beverage Law Update: March 2017

by Holland & Knight LLP on

Legalized Drug Use Impacts the Food and Beverage Industry - In the November 2016 general election, voters in Arkansas, Florida and North Dakota amended their state constitutions to authorize the use of marijuana for...more

Menu Labeling Excluded From ACA Repeal and Replace Bill

by Saul Ewing LLP on

The American Health Care Act (AHCA), released by House Republicans late on March 6, 2017, would repeal and replace certain portions of the Affordable Care Act (ACA). The legislation does not address section 4205 of the ACA,...more

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