News & Analysis as of

Prescription Drugs Compliance Audits

Health Care Compliance Association (HCCA)

In This Month’s E-News: June 2024

Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more

Goodwin

Common Bioresearch Monitoring Violations: Updates from FY 2021 to Now

Goodwin on

The Bioresearch Monitoring Program (BIMO), run by the U.S. Food and Drug Administration (FDA), oversees the conduct of on-site inspections and data audits of FDA-regulated research in support of new product development and...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Managed Care Compliance Conference - February 8th - 9th, 8:25 am - 3:45 pm CST

Can’t attend the conference in-person? The virtual Managed Care Compliance Conference, February 8–9, allows you to hear from industry professionals just like you—all from the comfort of your home or office. Geared towards...more

Health Care Compliance Association (HCCA)

[Event] 2022 Managed Care Compliance Conference - January 30th - February 1st, Phoenix, AZ

Attend our annual event for those who manage compliance at health plan providers. Explore topics and issues that are pertinent to industry professionals like you. Learn the latest practices, share strategies, and connect with...more

Proskauer - Minding Your Business

Beyond the Pandemic: Pharmaceutical Industry Compliance Considerations

Since the ongoing states of emergency were put in place in response to a health crisis, pricing in the pharmaceutical industry is under more of a microscope than usual. While the immediate focus may be on products that are...more

Holland & Knight LLP

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

Holland & Knight LLP on

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

BakerHostetler

340B Guidance: Eight Key Points Covered Entities Should Consider

BakerHostetler on

On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more

McDermott Will & Emery

The Case of Ophthalmic Drugs in Italy and France: A Lesson to Learn - Parallel Antitrust Investigations and Cooperation Between...

The recent investigations into two pharmaceutical companies active in the ophthalmic drugs market in Italy and France serve as a reminder of the cooperation that takes place between national competition authorities....more

Foley & Lardner LLP

340B Drug Pricing Program Update: Hospital Recertification and Recent Audit Activity

Foley & Lardner LLP on

As part of its expanded authority resulting from the Patient Protection and Affordable Care Act (PPACA), the Health Resources and Services Administration (HRSA) is continuing its efforts to ensure compliance with 340B Drug...more

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