News & Analysis as of

Life Sciences Audits

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: April 2024

Arguing that the National Science Foundation (NSF) was “intricately involved” when it made a $1.125 million fixed amount subaward, Oklahoma University (OU) objected to a recent finding by auditors for the NSF Office of...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: December 2023

Report on Research Compliance 20, no. 12  (December 2023) Although the National Science Foundation (NSF) allowed more than half the costs questioned by auditors for its Office of Inspector General (OIG), the California...more

Goodwin

Common FDA Bioresearch Monitoring Violations: Updates from FY 2022 to Now

Goodwin on

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

Fox Rothschild LLP

Key Considerations for Your Life Sciences IP Strategy

Fox Rothschild LLP on

Patent protection, regulatory exclusivity and product life cycle management should be at the core of any company’s life science development strategy. A well-integrated strategy will be critical to securing investments,...more

Arnall Golden Gregory LLP

There Is Never a Bad Time To Audit Your Supply Chain

In late December 2021, the United States banned imports of disposable gloves produced in Malaysia by manufacturer Brightway Holdings over allegations of forced labor....more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - June 2021

Latham & Watkins LLP on

Biden Releases Federal Budget Proposal for 2022: On May 28, 2021, President Biden released the proposed budget for fiscal year 2022, which would increase health spending by 23%. The proposal urges Congress to enact drug...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

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 9. In This Month's E-News: September 2020

Report on Research Compliance 17, no. 9 (August 20, 2020) - The Office of Management and Budget has published guidance for agencies and recipients of federal awards and contracts, finalizing a document issued in February...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 2. January 2020: In This Month’s E-News: February 2020

Report on Research Compliance 17, no. 2 (January 23, 2020) - - More than two years after Ozgur Tataroglu’s paper was retracted, the HHS Office of Research Integrity found that it and two grant applications contained...more

Morgan Lewis

China to Audit Foreign and Domestic Drug Makers on Accounting Compliance

Morgan Lewis on

In an effort to drive down medical costs, the PRC Ministry of Finance has announced it will audit 77 randomly selected drug makers in China in order to examine the companies’ costs and profits and determine the reasonableness...more

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