Series - Policy

In September 2025, the U.S. FDA launched a major enforcement campaign targeting direct-to-consumer (DTC) pharmaceutical advertising that misleads patients or downplays risks. Following a September 2025 presidential directive, the agency announced hundreds of enforcement actions—including over 100 cease-and-desist letters—signaling a zero-tolerance stance toward unbalanced or deceptive ads. While most of the letters focused on DTC content, FDA also sent letters for health care provider (HCP) promotion. The message: Government scrutiny and enforcement will significantly increase for biopharma as well as medical device promotion. This webinar includes regulatory compliance and drug advertising compliance experts who will dissect the FDA’s mindset and ways to proactively mitigate concerns.

In this webinar, you will learn:
– Drill down into FDA’s renewed enforcement government enforcement
– Dissect the implications of increased enforcement on the industry
– Identify specific cases that are clear examples for company concern
– Isolate the key principles for avoiding violations and demonstrating good faith

Is this the first time you’re attending BIO International Convention? This webinar is for you! We’ll cover all the basics of where to go and what to do - plus, you’ll get some insider tips from the BIO team on this year’s exciting event. 

If you haven't already registered, please learn more and register at convention.bio.org

The FDA has established the Split Real-Time Application Review (STAR) pilot program. The purpose of this program is to shorten the time from the date of a complete submission to the action date, in allowing earlier patient access to therapies that address an unmet medical need.

In this webinar, FDA staff will give an overview of the program, including the eligibility criteria for the pilot, and will answer your questions about participating in the program.

View this conversation highlighting how BIO member companies are strengthening food security and addressing climate change through biotechnology innovations in crop protection and efficient food production. Learn how regulation and policy can support agricultural innovation to protect our environment and our food supply.

View this conversation highlighting how BIO member companies are leveraging biotechnology innovations to enable advances in climate adaptation, mitigation, and resilience. Hear how diverse feedstocks and manufacturing processes are targeting emission reduction breakthroughs in hard-to-reach sectors. Learn how regulation and policy can better incentivize innovation and be structured to support new and emerging technologies throughout research, development, demonstration, and deployment.

​It's been one year since the passage of the IRA. The Centers for Medicare & Medicaid Services has moved forward implementing the law's various provisions, including the new Medicare negotiation program and the redesign of the Medicare Part D benefit. Learn the latest developments from our panel of experts, including how the IRA is impacting biopharmaceutical companies today. Panelists delve into other important issues beyond the IRA, including new developments in Medicaid, 340B, and the emergence of Prescription Drug Affordability Boards in a number of states.  

Following reauthorization by Congress of the SBIR/STTR Programs in 2022, there are new rules companies should familiarize themselves with concerning required disclosures of foreign affiliations or relationships with foreign countries. In addition to mandating disclosures prior to receiving SBIR awards, companies must also regularly update NIH following any changes to a disclosure. View this webinar organized by the Biotechnology Innovation Organization (BIO) for a comprehensive discussion on how to effectively navigate these new rules as you apply for SBIR awards.

This webinar is co-hosted by the National Institutes of Health (NIH) Seed Office.

View this important webinar for those invested in the broader biotech industry, "Understanding the Business Implications of Global Access and Benefit Sharing Policies." Tailored for members of BIO and a diverse community of stakeholders, this high-level session focuses on understanding the impact of recent developments in the global policy arena that will affect industry’s access to vital biologic materials and information. These policies have implications for the way industry will need to share the potential benefits that flow from their use of these physical and digital resources worldwide. Through interactive discussions led by seasoned experts across the Biotech ecosystem, explore the intricate relationship between national and global concerns, while uncovering the potential implications for your company. This webinar will equip you with the knowledge and insights essential to thriving in an ever-evolving global biotech landscape for an empowering dialogue that promises to shape the future of biotechnology.

U.S. Department of Justice (DOJ) statistics suggest that enforcement will be a top government priority in 2023, including for pharma/life sciences. Warning or untitled letters from the U.S. Food and Drug Administration (FDA) will serve as ammunition for DOJ cases. Statements about product safety will be heavily scrutinized.

Do you know what to watch out for? Has your company trained its employees and marketing agencies on how to appropriately implement the requirements for promotion? What activities require extra vigilance? The prior downturn in enforcement can be linked to the development of a response to COVID-19, which diverted government resources across the board. Now trends suggest the FDA, DOJ, and Office of Inspector General (OIG) will return to active healthcare enforcement in 2023 for violations of the Food Drug and Cosmetic Act (FDCA), False Claims Act and the Anti-Kickback Statute in part attributable to the goal of obtaining additional financial recoveries.

This webinar hosted by the Biotechnology Innovation Organization (BIO) has these learning objectives:
—Understand the current trends for government enforcement
—Dissect the compliance implications of increased enforcement on the industry
—Identify specific cases that are clear examples for company concern
—Isolate the key principles for avoiding violations

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The Center for Communication Compliance (CCC) helps biopharmaceutical companies achieve efficient, compliant innovation in a digital world through its proprietary on-demand business solutions in education, technology, and change management.

The CCC eLearning System has set an unmatched standard for confirming regulatory competency through engaging mastery tests and expert education content across more than a dozen course options.

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