PwC Report: Regulatory Innovation Should Adapt to New Health Economy
Consumers and drug and device manufacturers are changing practices and shifting attitudes toward the Food and Drug Administration (FDA). Increased pressures for speedy access to breakthrough drugs and medical devices, and a focus on value in addition to medical benefit, are driving these changes.
A new report from PwC’s Health Research Institute (HRI) based on findings from surveys of consumers and senior industry leaders in the drug and medical device sector has uncovered changing practices and shifting attitudes toward the Food and Drug Administration (FDA). In its report, “The FDA and industry: A recipe for collaborating in the New Health Economy,” 43% of survey respondents said they are willing to have their products judged based on both clinical and economic value, compared to just 14% in 2010.
Read the full release here.
Additional key findings of the report include:
- Seventy-eight percent of executives said that the FDA has improved the quality and frequency of its communications in the past two years.
- Seventy-six percent think that the agency provides actionable feedback and 70 percent think it offered more applicable guidance, rules and regulations in the past two years.
- Seventy-one percent believe that the FDA can accelerate approval programs by balancing swifter approval with increased post-market surveillance.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
