News & Analysis as of

The United States Food and Drug Administration Centers for Medicare & Medicaid Services

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 -

Impact of Marijuana on Maine Workers’ Compensation

by PretiFlaherty on

Marijuana use in the State of Maine has been in a state of flux over the past several years. The introduction of the Maine Medical Use of Marijuana Act, Maine Workers’ Compensation Appellate Division decisions, and a recent...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

Senate Confirms Verma as CMS Administrator; Trump Nominates Gottlieb for FDA, Hargan as Deputy HHS Secretary

by Reed Smith on

The Senate has approved the nomination of Seema Verma to be CMS Administrator on a vote of 55 to 43. In other nomination news, President Trump has nominated Scott Gottlieb to be Commissioner of Food and Drugs. Dr. Gottlieb is...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

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

FDA Issues Discussion Paper on LDTs

by King & Spalding on

Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed...more

FDA Advances LDT Dialogue with New Discussion Paper Containing Updated CMS/FDA Oversight Proposal

by Reed Smith on

On January 13, 2017, the Food and Drug Administration (FDA) released a discussion paper concerning an updated proposed framework for oversight of laboratory developed tests (LDTs). According to FDA, the updated proposal is...more

Blog: FDA Issues Discussion Paper on Laboratory Developed Tests

by Cooley LLP on

The U.S. Food and Drug Administration (FDA) issued today a Discussion Paper on Laboratory Tests (LDTs). The Discussion Paper follows draft guidance issued by the FDA in 2014 (2014 Draft Guidance) and a stakeholder workshop...more

Implications of the Medicare and Medicaid Provisions in the 21st Century Cures Act

by K&L Gates LLP on

On December 7, 2016, Congress passed the 21st Century Cures Act (the “Act”). The Act began as a proposal to increase funding to the National Institutes of Health (“NIH”) and streamline the Food and Drug Administration’s...more

House Passes 21st Century Cures Act

by King & Spalding on

On November 30, 2016, the House of Representatives passed the 21st Century Cures Act, a bill intended to modernize health care delivery and speed up and improve medical research and innovations by removing bureaucratic...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

CMS, FDA Parallel Review Program for Medical Devices Extended Indefinitely

by McDermott Will & Emery on

On October 24, 2016, the US Food and Drug Administration and the Centers for Medicare & Medicaid Services announced the full implementation and indefinite extension of the Program for Parallel Review of Medical Devices (the...more

FDA & CMS Extend Medical Device Parallel Review Program

by Reed Smith on

The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have announced that they are making permanent their “Program for Parallel Review of Medical Devices,” which is now operating as a...more

It’s Hunting Season. For Unicorns? Lawsuit Against Theranos Signals Trend In Investors Going After Late-Stage Start-ups

Last week brought more bad news for private blood testing company Theranos Inc., as San Francisco-based Partner Fund Management L.P. (“PFM”) launched a suit claiming that it was duped into making a $96.1 million investment in...more

Washington Healthcare Update

by McGuireWoods LLP on

1. Congress - Senate - FDA Supports Expanded Authority Over Cosmetics - In an Oct. 5 letter to Senator Dianne Feinstein (D-CA), the Food and Drug Administration (FDA) says its current legal authority over...more

Capitol Hill Healthcare Update

by BakerHostetler on

Congress completed work last week on a stopgap budget that keeps the government open until a post-election lame-duck voting session in December, when lawmakers are expected to move on legislation dealing with medical...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: Congress remains in recess, but members write letters on Mylan’s EpiPen…CBO says repealing Part B Demo would cost $395 million…CMS releases data on hospice utilization and finds spending and utilization vary in...more

NIH Finalizes New Drug and Device Clinical Trial Reporting Requirements

by Reed Smith on

The National Institutes of Health (NIH) has finalized the requirements for submitting clinical trial information for applicable clinical trials of drug products (including biological products) and device products on...more

AGG Food and Drug Newsletter - September 2016

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

by Foley & Lardner LLP on

Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

151 Results
|
View per page
Page: of 7
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
Feedback? Tell us what you think of the new jdsupra.com!