Life Sciences

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus

On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national health priorities and potentially marking a significant shift in the U.S. regulatory landscape for drug development. For life sciences companies, this program presents both a unique opportunity and new strategic considerations; however, while the promise of a much shorter review window is enticing, life sciences innovators would be wise to proceed with caution.

Scientists or physicians analyze sample

Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key personnel on current regulations and any changes, and involve them in risk identification and mitigation strategies. Foster a culture of shared responsibility through ongoing training and open communication. Keep detailed documentation of the reasoning behind your procedures and policies, and store all standard operating procedures (SOPs) in a central, easily accessible location. Finally, implement a robust system for managing data and documents to ensure that all necessary information is readily available for internal and external monitors, as well as regulatory agencies.

Recently, Attorney General Pam Bondi purportedly issued an internal memorandum in response to Executive Order 14187 (“Protecting Children from Chemical and Surgical Mutilation”) concerning the treatment of transgender minors by medical practitioners, hospitals, clinics, and pharmaceutical companies. The memo set forth guidance for all Department of Justice (DOJ) employees to investigate individuals and entities who provide gender-affirming care to minor patients. To be clear, the memorandum—which has been posted in various locations on the internet and widely reported on by various media outlets but has not been verified as authentic by Husch Blackwell—is an internal policy statement directed to DOJ personnel and is not law. While it purports to issue “guidelines” pursuant to an executive order from the President, that executive order is itself under scrutiny (and has been partially enjoined).

blog series tag - Navigating Life Sciences Transactions

This post is the fifth in our five-part series, Navigating Life Sciences Transactions, where our team of attorneys provides essential strategies and insights for successful life sciences transactions.

Throughout this series, we’ve explored the key elements of successful life sciences transactions—from structuring collaborations and securing funding to protecting intellectual property and navigating regulatory complexities.

Yet, even when companies understand these fundamentals, transactions don’t always go as planned. In our work with biotech, medtech, digital health, and research-driven companies, we’ve seen common missteps that can slow deals down, create compliance risks, or weaken long-term business outcomes.

blog series tag - Navigating Life Sciences Transactions

This post is the fourth in our five-part series, Navigating Life Sciences Transactions, where our team of attorneys provides essential strategies and insights for successful life sciences transactions.

Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to market. CRAs, which govern the conduct of clinical trials, are essential for detailing which party will comply with the regulatory requirements while facilitating the commercialization of new drugs, devices, and digital health solutions.

blog series tag - Navigating Life Sciences Transactions

This post is the third in our five-part series, Navigating Life Sciences Transactions, where our team of attorneys provides essential strategies and insights for successful life sciences transactions.

With the SXSW Health and MedTech conference in full swing, it’s a good time to reflect on some fundamental Intellectual Property (IP) strategies that can help safeguard your Life Sciences and MedTech business and maximize its value now and into the future.

IP is often one of the most valuable assets a company can own. Whether you’re preparing to sell a business, enter into a joint venture, or acquire another company, understanding the scope of your IP portfolio is essential. For in-house counsel, founders, corporate executives, and other legal professionals, navigating the complexities of IP ownership and licensing can make or break a deal.

blog series tag - Navigating Life Sciences Transactions

This post is the second in our five-part series, Navigating Life Sciences Transactions, where our team of attorneys provides essential strategies and insights for successful life sciences transactions.

What Investors Look for in Early and Late-Stage Funding Rounds and How Regulatory Compliance Impacts Valuation

For early-stage life sciences and health tech companies, raising capital is about more than demonstrating scientific promise. Investors are increasingly focused on regulatory preparedness, reimbursement strategy, and risk allocation—factors that can significantly impact valuation and long-term viability.

blog series tag - Navigating Life Sciences Transactions

This post is the first in our five-part series, Navigating Life Sciences Transactions, where our team of attorneys provides essential strategies and insights for successful life sciences transactions.

AI, Medical Devices, Digital Health, and the Future of Healthcare Transactions

Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions.

blog series tag - Navigating Life Sciences Transactions

The life sciences industry is built on breakthroughs and partnerships. From early-stage biotech startups to established medtech and pharma companies, success often depends on navigating complex business transactions, securing funding, protecting intellectual property, and aligning with regulatory requirements.

At Husch Blackwell, we’ve worked alongside drug manufacturers, device companies, digital health innovators, academic medical centers, CROs…

Research into psychedelic-assisted therapy receives funding in the National Defense Authorization Act for Fiscal Year 2024.

In an epoch marked by rapid innovation in mental health treatments, a paradigm shift is on the horizon for the well-being of our armed forces personnel. Psychedelic-assisted therapy has surfaced as an innovative intervention for ailments such as depression, traumatic brain injury (TBI), and—perhaps most widely applicable to military personnel—post-traumatic stress disorder (PTSD). Combat veterans are significantly susceptible to PTSD, and the debilitating impact of PTSD can last a long time.