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McDermott Will & Emery

FDA Gives Companies a New Way to Fight Misinformation

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Misinformation shared by independent third parties presents a significant public health concern because it can lead patients and healthcare providers to forgo treatments that are safe and effective or choose treatments that...more

Alston & Bird

Health Care Week in Review: House Committee on Oversight and Accountability Held a Hearing on PBMs; HHS Reorganizes Technology,...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Bradley Arant Boult Cummings LLP

MDMA DOA at FDA Advisory Committee

Avid readers know we have speculated that the legalization of psychedelics as a prescription medicine was “closer than ever.” Unfortunately, for proponents of the legalization of psychedelics like MDMA, progress is rarely a...more

Alston & Bird

Health Care Week in Review: House Held a Markup of 23 Bills; Senators Announced a Proposal on Primary Care Payment Reform

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: House Passes Appropriations Bill and Senate Expected to Vote Shortly, CMS Unveils the ACO Primary Care...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Troutman Pepper

Reassessing Oregon’s Drug Policy: A Shift Toward Recriminalization

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In the grand experiment of American democracy, it is often said that states serve as laboratories, testing policies that challenge the status quo without risking the stability of the whole. Oregon, known in recent years for...more

Quarles & Brady LLP

It's (Apparently) Never Too Late Part II: DEA & Morris & Dickson Settle

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This week, DEA announced it has entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the protracted dispute born out of a May 2, 2018 Order to Show Cause (“OTSC”) and Immediate...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Manatt, Phelps & Phillips, LLP

The Fight to End the Nation’s Overdose Epidemic and Restore Compassionate Care

In 2021, drug-related overdose deaths topped 107,000. Despite a nearly 50% decrease in opioid prescribing over the past decade, drug overdose mortality continues to trend in the wrong direction. In the face of these...more

Console and Associates, P.C.

Some OTC Supplements Contain Tadalafil, According to the FDA

In recent months, the Food and Drug Administration (FDA) announced several recalls related to natural supplements that were found to contain tadalafil and its analogs, the active ingredients in Viagra and Cialis. In its...more

Akin Gump Strauss Hauer & Feld LLP

Outlook for Action on Mental Health and Substance Use Disorder Initiatives

Prompted by rising rates of overdose deaths, suicides and incidence of mental illness in at-risk populations, such as children, Congress has spent the better part of the year working in a bipartisan manner to develop and...more

Knobbe Martens

U.S. FDA Approves Monkeypox Treatment Formulation

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(May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of TPOXX (tecovirimat) for the treatment of...more

Hogan Lovells

Publicité et communication sur les dispositifs médicaux : la Charte française tant attendue enfin publiée !

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L'arrêté ministériel fixant la Charte relative à la qualité des pratiques professionnelles de présentation, d'information ou de publicité des dispositifs médicaux à usage individuel, des autres produits de santé et de tout...more

Hogan Lovells

Advertising and communication on medical devices: France’s long-awaited Charter finally published!

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The French ministerial order laying down the Charter on the quality of professional practices for the presentation, information or promotion of medical devices for individual use, other health products and any associated...more

Patrick Malone & Associates P.C. | DC Injury...

Opioid court cases offer hard evidence: Path to justice can be rocky

Patients who say they were injured by wealthy corporations must possess great fortitude as they seek justice in the civil system, as has been reaffirmed by the courts in California and Oklahoma that rejected separate cases...more

Patrick Malone & Associates P.C. | DC Injury...

Kids now can get Covid shots. Will they? And what about the new anti-Covid pills?

Even as the coronavirus batters parts of the country, notably the Mountain West, public health officials are pointing to key ways in which Americans could safely and effectively further quell the pandemic that has claimed...more

Brownstein Hyatt Farber Schreck

Summary of Health Care Provisions in Energy & Commerce Reconciliation Bill

This week, the House Energy and Commerce Committee approved sweeping health care legislation as part of the Democratic Congress’ plan to enact a $3.5 trillion legislative package through budget reconciliation. The committee...more

Patrick Malone & Associates P.C. | DC Injury...

U.S. ends confusion and expands prescribing of opioid-fighting medication

Health workers with legal prescribing privileges have gotten newly revised federal guidelines — once again — making it easier for them to help those addicted to powerful opioid painkillers by prescribing buprenorphine,...more

Hogan Lovells

Safeguarding drug development at academic institutions

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Academic institutions and faculty engaged in developing novel drug therapies are navigating an increasingly complex compliance landscape. ...more

Arnall Golden Gregory LLP

OTC Monograph Reform – Takeaways from FDA’s Webinar on Expedited Administrative Orders

On January 27, 2021, the Food and Drug Administration held its second webinar since the enactment of the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) in March 2020, to further discuss over-the-counter...more

Patrick Malone & Associates P.C. | DC Injury...

Consultant to pay $573.9 million as consequence of its sketchy opioid advice

The opioid abuse and drug overdose crisis has tarred yet another of the nation’s business titans: McKinsey, a globally renowned consulting firm, has discovered that providing corporate clients sketchy advice about addictive,...more

Patrick Malone & Associates P.C. | DC Injury...

U.S. suit accuses Walmart of fueling deadly opioid crisis via its pharmacies

The stain of the nation’s opioid abuse and drug overdose crisis has spread now to Bentonville, Ark., as federal prosecutors have sued Walmart, accusing the nation’s largest retailer of improperly allowing its pharmacists to...more

Hogan Lovells

[Webinar] Looking ahead to 2021: Impacts of the election for the life sciences and health care industry - November 19th, 12:30 pm...

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Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more

Oberheiden P.C.

DEA Compliance for 2021 - How the DEA’s 2021 Proposed Aggregate Production Quotas Affect Pharmaceutical Companies and Society

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The DEA struggles to balance the pressing need to provide pain relief for those suffering from the novel coronavirus with the ongoing effort to reduce the opioid epidemic in the United States. I. Overview on the DEA and the...more

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - September 2020

As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more

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