AI Agents in Action: How Digital Colleagues Are Changing the Way We Work - On Record PR
Innovation in Compliance: Mastering Communication: Insights from Dr. Dennis Cummins on Speaking and Selling without Selling
Fox on Podcasting: PodPage and Beyond: Elevating Listener Experience with Dave Jackson
Innovation in Compliance: The Future of Compliance Training: AI, Adaptive, Learning, and Cultural
Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
The Rise of OTAs in Defense Contracting: Opportunities, Risks, and What Contractors Need to Know
Future-Ready – Equipping MBD Teams to Navigate and Leverage Emerging Technologies
AI in eDiscovery Today: An Open Conversation
Innovation in Compliance: Allison Lagosh on Proactive Compliance Planning for Regulatory Changes
Innovation in Compliance: Maximizing LinkedIn for Personal and Professional Branding with Carol Kaemmerer
Innovation in Compliance: The Critical Importance of Mobile Application Security: Insights from Subho Halder
Meet Phil Leslie, Cornerstone Research's New Chief Technology and Innovation Officer
Innovation in Compliance: Integrating AI in Compliance and Risk Management with Jana Brost
The Future of Supply Chains: Chris Andrassy on Using AI to Predict & Prevent Disruptions
Innovation in Compliance: Break the Five Lies - A Conversation with John Kormanik
Compliance Tip of the Day: Using Supply Chain to Innovate in Compliance
Innovation in Compliance: Innovative Approaches to Compliance and Training with Catherine Choe
Innovation in Compliance: Exploring the Fractional COO Model with La Tonya Roberts
Innovation in Compliance: Design-Centric Compliance Training with Karen Oddo
Innovation in Compliance: Strategic Compliance in Regulated Industries with Kerri Reuter
The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based...more
Goodwin’s 2025 Rare Disease Symposium, held on February 5 in Boston and virtually, gathered patient advocates and caregivers, providers, researchers, biotech and medtech leaders, investors, and policy experts to discuss the...more
Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Lauren welcome Dr. Ehsan Samei and Dr. Susan Halabi, leaders of the new Triangle CERSI, which stands for the Center of Excellence in Regulatory...more
Originally published in Genetic Engineering News on October 10, 2023. Reprinted with permission. The biotechnology sector has long been characterized by its constant innovation, rapid technological progress, and unyielding...more
On September 12, 2022, President Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The objective of the Executive Order...more
Antibodies are part of the body’s adaptive immune response to defend itself against toxins and pathogens, such as bacteria and viruses. When the body identifies a foreign entity, it mounts a cascading response that culminates...more
2020 Filings While there was a more than 20 percent decline in the number of securities class actions filed in 2020 (approximately 330 cases) as compared to 2019 (approximately 430 cases), the percentage of cases filed...more
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
The Prescription Drug User Fee Act of 2017 (PDUFA VI) authorizes the U.S. Food and Drug Administration (FDA) to assess fees (PDUFA fees) when applicants submit new drug applications (NDAs). PDUFA fees are substantial. For...more
On April 2, 2019, U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., and Deputy Commissioner for Policy, Legislation and International Affairs, Anna Abram, released a statement on the status of FDA’s...more
20 years or five months? On March 8, 2019, nearly 20 years after AquaBounty Technology discovered a novel approach to increase the growth of Atlantic salmon, the U.S. Food and Drug Administration (FDA) finally “deactivated”...more
The U.S. Food and Drug Administration (FDA) recently released its Plant and Animal Biotechnology Innovation Action Plan (“Action Plan”). The Action Plan provides an overview of the key priorities FDA expects to pursue through...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Plan to “Advance Plant, Animal Biotechnology Innovation” - U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has issued a statement announcing the...more
On October 30, 2018, the U.S. Food and Drug Administration (FDA) published a statement by FDA Commissioner Scott Gottlieb, M.D., and FDA Deputy Commissioner Anna Abram regarding FDA’s new action plan to advance plant and...more
On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more
The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more
Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more