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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 -

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

Capitol Hill Healthcare Update

by BakerHostetler on

Trump’s speech: Clarity on ACA next steps? President Trump will address a joint session of Congress on Tuesday, and the expectation is that he will use the primetime moment to outline – at least in broad strokes – his...more

Capitol Hill Healthcare Update

by BakerHostetler on

Meeting privately with Senate Republicans to discuss next steps on the ACA was among the first actions taken last week by the new Secretary of the U.S. Department of Health and Human Services Tom Price. But GOP senators left...more

Capitol Hill Healthcare Update

by BakerHostetler on

Three weeks into President Trump’s administration, the Senate on Friday narrowly approved Tom Price as Secretary of the U.S. Department of Health and Human Services (HHS), elevating the former orthopedic surgeon as Trump’s...more

Blog: Price Confirmed For HHS Secretary, Other Key Agency And Department Positions Next To Be Filled

by Cooley LLP on

Around 2 a.m., the Senate voted along party lines to confirm Representative Tom Price to become Secretary of the Department of Health and Human Services. The vote was 52-47 with no Democrats voting in favor. With repeated...more

CFSAN Director Anticipates “Tweaks,” Not Rollbacks Despite Administration’s De-Regulation Emphasis

by Kelley Drye & Warren LLP on

Dr. Susan Mayne, Director of FDA’s Center for Food Safety and Applied Nutrition, spoke on Thursday to the DC section of the Institute of Food Technologists. Responding to questions from the audience, Dr. Mayne was asked to...more

Capitol Hill Healthcare Update

by BakerHostetler on

House Speaker Paul Ryan last week set a deadline of the end of March for repealing most of the Affordable Care Act (ACA), as other Republican leaders and conservative rank-and-file lawmakers advocated competing policy...more

A&B Healthcare Week in Review

by Alston & Bird on

On January 9, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft...more

Capitol Hill Healthcare Update

by BakerHostetler on

At GOP retreat, consensus on healthcare elusive - House and Senate Republicans emerged from a policy retreat last week in Philadelphia with no agreement on next steps in their plan to repeal and replace the Affordable...more

Uncertainty rises about leadership in nation’s top health posts

Although attention has focused on the GOP-promised repeal and replacement of the Affordable Care Act, other big changes also are afoot in the federal government that will have significant effects on health care in this...more

Capitol Hill Healthcare Update

by BakerHostetler on

The House on Friday gave final congressional approval to a budget blueprint that authorizes separate filibuster-proof legislation Republicans will use next month to repeal much of the Affordable Care Act...more

The ERISA Litigation Newsletter - December 2016

by Proskauer Rose LLP on

This month Richard Zall, Chair of Proskauer's Health Care Department, explores developments likely to occur with respect to the Affordable Care Act as a result of the new administration. In our Rulings, Filings and...more

21st Century Cures Act offers array of holiday gifts to healthcare providers

by DLA Piper on

The 21st Century Cures Act, a rare beneficiary of broad bipartisan support, has been signed into law by President Barack Obama. The law has received much public acclaim for its $4.8 billion in new funding over the next...more

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

by Ballard Spahr LLP on

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

New Law Permits Stand-Alone Health Reimbursement Arrangements (HRAs) For Small Employers

On December 13, 2016 President Obama signed into law the 21st Century Cures Act. The law had been approved with bipartisan support in the House by a vote of 392 to 26 and in the Senate by a vote of 94 to 5. The law addresses...more

The Trump Administration: The Future of Health Care

The election of Donald J. Trump as the 45th President of the United States, along with the Republican control of the majority of both the House of Representatives and the Senate, will likely set in motion a major overhaul of...more

Capitol Hill Healthcare Update

by BakerHostetler on

The Senate this week is likely to give final congressional approval to legislation that adds billions of dollars for biomedical research and aims to speed the discovery and development of new drugs and medical devices. The...more

Capitol Hill Healthcare Update

by BakerHostetler on

After months of debate and partisan wrangling, the House on Wednesday voted 392-26 to pass the “21st Century Cures” bill designed to accelerate the development of new drugs and medical devices as well as increase federal...more

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