News & Analysis as of

Supply Chain Healthcare

Health Care Compliance Association (HCCA)

Privacy Briefs: August 2024

On July 19, Change Healthcare Ince. filed a breach report with HHS Office for Civil Rights (OCR) concerning its mammoth ransomware attack and breach. The organization’s breach report to OCR identifies just 500 individuals as...more

Epstein Becker & Green

Recent Supreme Court Decisions and the DSCSA

Epstein Becker & Green on

The recent Supreme Court decisions of SEC v. Jarkesy and Loper Bright Enterprises v. Raimondo have the potential to meaningfully impact the implementation and enforcement of the Drug Supply Chain Security Act (“DSCSA”) as...more

Epstein Becker & Green

FDA Guidance on DSCSA Small Dispenser Exemption and Exemptions and Waivers for Other Trading Partners

Epstein Becker & Green on

In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more

McCarter & English, LLP

New Jersey Statutory Update Part I

Every year, the New Jersey legislature passes statutes that impact healthcare beyond rate increases under the Medicaid program. Last year was no different, and the discussion below highlights some of those statutes, such as...more

Axinn, Veltrop & Harkrider LLP

Can an Enhanced India-U.S. Partnership Reduce Drug Supply Chain Issues?

In an effort to enhance collaboration, the Indian Pharmaceutical Alliance (IPA) recently proposed that a more formal preferred partnership between the U.S. and India can not only lower drug prices in the U.S. but can improve...more

Jones Day

Canadian Drug Importation May Undermine Intellectual Property Protection

Jones Day on

The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more

Procopio, Cory, Hargreaves & Savitch LLP

How Private Equity Firms Select Investment Targets and Build Capital: Insights for Entrepreneurs

What do private equity and growth capital investors look for when adding new companies to their portfolio, and what strategies do they apply to help those companies optimize capital? Procopio Partner and Mergers &...more

Foley Hoag LLP - White Collar Law &...

Congressional Investigations: A Review of Investigations Likely to Continue in 2024 and into the 119th Congress

This is the sixth in our 2024 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...more

Manatt, Phelps & Phillips, LLP

FDA Approves Florida’s Application to Import Drugs from Canada

On January 5, 2024, the Food and Drug Administration (FDA) authorized the state of Florida’s proposal under the Section 804 Importation Program (SIP) for a period of two years. FDA’s action marks the first time a state drug...more

Proskauer Rose LLP

Q&A: What does 2024 have in store for European M&A?

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There is a wealth of dry powder to spend but 2023 has seen M&A deal activity hampered by rising costs of debt, unstable markets, supply chain issues, general political uncertainty, and fear of global recession. So, what does...more

Troutman Pepper

Navigating the Future of Pharmacy Law: Key Takeaways From the 2023 American Society of Pharmacy Law Conference

Troutman Pepper on

Earlier this month, the American Society of Pharmacy Law hosted its annual conference in San Antonio, TX. This gathering of industry leaders provided a unique opportunity to delve into the ever-evolving landscape of pharmacy...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - October 2023 #3

News Briefs - FTC Aims to Take Action on Non-Competes, M&A Enforcement - Healthcare lobbying organizations' efforts to carve out industry-specific exemptions in recently proposed Federal Trade Commission policies are...more

Jones Day

FDA Announces Delayed Enforcement of Looming Supply Chain Requirements for Drugs Until 2024

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With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more

Foley & Lardner LLP

Recommendations for Managing Cybersecurity Threats in the Manufacturing Sector

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In the hyper-connected era of smart manufacturing, accelerated by “Industry 4.0,” the manufacturing sector is undergoing a digital revolution. By leveraging technologies such as advanced automation, artificial intelligence,...more

Quarles & Brady LLP

Amidst Ongoing Manufacturer Restrictions, 340B Covered Entities and Contract Pharmacies Get Creative

Quarles & Brady LLP on

Although 340B-participating covered entities likely don’t need the reminder, numerous manufacturers continue to significantly restrict 340B pricing available via traditional “bill to/ship to” contract pharmacy models, with...more

Nelson Mullins Riley & Scarborough LLP

Two new FDA Drug Supply Chain Security Act Guidances to help Pharmaceutical Supply Chain Partners Comply with the DSCSA’s move to...

The DSCSA, enacted in 2013, requires entities in the pharmaceutical supply chain to implement security measures to prevent the introduction of counterfeit and illegitimate drugs into the market. One of these measures is the...more

Quarles & Brady LLP

More Guidance Released from FDA for Drug Supply Chain Security Act Compliance

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The Food and Drug Administration (“FDA”) released additional guidance documents on Wednesday, August 30th pertaining to the enhanced drug distribution security requirements under the Drug Supply Chain Security Act (“DSCSA”). ...more

Jones Day

Decarbonizing the Health Care Sector

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At a global level, the decarbonization of the health care sector has been coordinated by the World Health Organization (WHO) COP26 Health Programme, launched at the COP26 climate summit in November 2021. Under this program,...more

Goldberg Segalla

FDA to EPA: Pump the Brakes on New EtO Rules During Supply Chain Shortage

Goldberg Segalla on

With COVID diagnoses spiking across the United States this summer, we cannot yet claim that the pandemic is behind us. In fact, we are still experiencing residual medical device and equipment shortages, which has caused...more

Knobbe Martens

FDA Updates Medical Device Shortages List

Knobbe Martens on

The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more

Bracewell LLP

PRG Pulse 2022 Post-Election Analysis

Bracewell LLP on

The Big Picture - Congressional Overview - American voters delivered a decidedly mixed message to Washington on Tuesday, seemingly handing Republicans narrow control of the U.S. House of Representatives and a nominal check...more

White & Case LLP

US de-SPAC & SPAC data & statistics roundup - HI 2022

White & Case LLP on

US de-SPAC M&A deal value has contracted significantly during the first half of 2022, sliding from US$231.31 billion during the buoyant H1 2021 period to just US$26.29 billion for H1 2022. A wider M&A slowdown as a result of...more

Quarles & Brady LLP

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think

Quarles & Brady LLP on

On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more

White & Case LLP

US De-SPAC & SPAC data & statistics roundup - Q1 2022

White & Case LLP on

US De-SPAC M&A Commentary - US De-SPAC M&A deal value totaled US$8.13 billion from 16 De-SPAC deals in Q1 2022. This was significantly lower than the record US$155.43 billion of De-SPAC deal value from 81 deals reported at...more

Harris Beach PLLC

Division Y-Cyber Incident Report for Critical Infrastructure Act of 2022 Becomes Law, with Regulations Expected by 2025

Harris Beach PLLC on

Division Y – Cyber Incident Reporting for Critical Infrastructure Act of 2022 was signed into law by President Biden on March 15. Highlights of the Act include: ...more

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