Search Results: Health Care

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Common GCP Bioresearch Monitoring Violations

The U.S. Food and Drug Administration’s (FDA’s) Office of Bioresearch Monitoring Operations (OBIMO) oversees domestic and foreign agency field inspections for clinical and non-clinical research. In particular, OBIMO manages the Bioresearch Monitoring (BIMO) Program which conducts onsite field inspections and data monitoring to ensure institution and industry compliance with FDA’s…

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PE Investment in Health Care Attracting Greater Federal Scrutiny

Private equity investment in health care companies has garnered increasingly critical attention from the federal government, including recent scrutiny by Congress in March 2021, when the Oversight Subcommittee of the U.S. House of Representatives’ Ways and Means Committee held a hearing on “Examining Private Equity’s Expanded Role in the U.S….

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Biden Executive Order Targets Competition in Healthcare, Life Sciences to Spur Economic Activity

On July 9, 2021, President Joe Biden issued an Executive Order (the “Order”) designed to promote competition in the American economy. The Order describes the administration’s concerns with competition in several markets, including healthcare, noting that industry consolidation has exacerbated racial, income and wealth inequality and emphasizing that robust competition is critical…

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Promotion of Devices Subject to the FDA’s COVID-19 Enforcement Policies

The Biden Administration’s withdrawal of the Trump Administration’s proposal to exempt 84 medical device types from the FDA’s premarket notification, or 510(k), requirement, underscores the promotional framework that developers and marketers of these devices are subject to.  The Trump Administration proposal included devices critical to combating the COVID-19 public health…

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Drug Development Scorecard — A Guide for Companies Navigating the FDA Drug and Biologic Development and Approval Process

Developing a new drug or biologic is a complex process. Based on our extensive experience advising early-stage and clinical-stage companies, the Goodwin FDA team created this “scorecard” for companies to use as a guide as they navigate the FDA drug development and approval process. The drug development scorecard (or checklist)…

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Disrupt + Innovate + Transform: Key Regulatory Issues for Digital Health Companies Webinar

Goodwin Life Sciences and Healthcare partner Roger Cohen and associate Anne Brendel along with Life Sciences and FDA associate Steven Tjoe kicked off Goodwin’s multi-part webinar series “Disrupt + Innovate + Transform: A Healthcare Webinar Series” with “Key Regulatory Issues for Digital Health Companies” discussing the key regulatory issues affecting…

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EDPB Clarifies Scientific Research GDPR Compliance; Key Questions for US Sponsors Remain

Last month, the European Data Protection Board (“EDPB”) issued additional guidance on the application of the General Data Protection Regulation (“GDPR”) in the area of scientific health research. You can read our summary of the key takeaways here. While the EDPB’s responses offer some clarifications, many obstacles and complications remain…

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2020 Year in Review: Securities Litigation Against Life Sciences and Healthcare Companies

Despite the turmoil and disruption of 2020, plaintiffs’ lawyers and courts appear to have adapted readily to our “new normal.” Although at lower rates than previous years, plaintiffs’ firms continued to file securities class actions against publicly traded pharmaceutical, biotechnology, medical device and healthcare product and services companies in 2020,…

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