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…
Rule 10b5-1 trading plans have faced increased scrutiny since the onset of the COVID-19 pandemic and the corresponding public focus on stock sales by executives of public life sciences companies. On June 7, 2021, SEC Chairman Gary Gensler continued that scrutiny when he delivered prepared remarks to the Wall Street…
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)…
On May 19, 2021, the U.S. Food and Drug Administration (FDA) released an updated guidance in draft form on how to complete the Statement of Investigator form (Form FDA 1572). The guidance addresses frequently asked questions from sponsors, clinical investigators, and institutional review boards (IRBs), and it provides new information…
Companies often use equity incentives to reward key members of their workforce and attract and retain the best talent. In the UK, companies have typically granted EMI options (a government‑backed, tax-advantageous share option) or unapproved options. However, where a company is unable to grant EMI options (for example, because the…
Whether you are a director, or a member of an in-house legal, human resources, or internal audit team, there are sensitive scenarios that occur daily in life sciences companies that trigger the need for an internal investigation. Goodwin has crafted an “In-House Counsel’s Guide” that sets forth a framework of…
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…
Innovators in life sciences at companies and universities often collaborate and conduct research under a joint research agreement (JRA). The Cooperative Research and Technology Enhancement Act of 2004 (the “CREATE Act”) was enacted to promote collaboration and cooperative research between different entities. The United States Patent and Trademark Office (“USPTO”)…
The use of special purpose acquisition companies, or SPACs, as an alternative to the traditional IPO process has gained significant traction over the past few years and in 2020 in particular. While these transactions have historically focused more on the tech space, with top-tier biotech investors such as Perceptive Advisors,…
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…