In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development and approval of gene therapy products on July 11, 2018. As a follow up to its milestone gene therapy product approvals in 2017 (see here and here), FDA had promised to develop gene therapy-specific guidelines to help spur innovation in this area by providing industry with useful advice and greater regulatory clarity. However, it’s fair to say that we were not expecting to see this large of a transparency commitment by the Agency, which concurrently issued six new guidance documents. FDA Commissioner Scott Gottlieb also issued a lengthy same-day statement on the Agency’s “efforts to advance development of gene therapies,” in which he stated in part: Continue Reading FDA Releases Series of Gene Therapy Guidance Documents: From Drug Development to Postmarket Monitoring
Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug competition issues, with the end goal of affecting drug prices, as well as current figures related to this year’s new drug and biologic approvals. A large proportion of those new products took advantage of the Breakthrough Therapy program and other expedited development/review pathways. Today we’ll begin where we left off and consider how the newest expedited review pathway, the RMAT Designation program, is doing one year after its creation by Congress. Continue Reading FDA 2017 Year in Review: Therapeutic Products, Part 2
In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine.” Continue Reading FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies
Join us next Wednesday, February 15 from 1pm – 2pm Eastern for the final installment of our three-part webinar series on the 21st Century Cures Act (the “Cures Act”). Part III of the series will focus on the Cures Act’s impact on the FDA and will have some great takeaways for anyone who interacts with the FDA or has an interest in the Cures Act.
In this presentation, our colleagues Bethany Hills and Joanne Hawana will discuss the following FDA-related provisions of the Cures Act and take a deep dive into the practical implications and implementation processes for each of:
- Regenerative Medicine
- Medical software/digital health
- FDA restructuring/structural improvements
- Health care economic info and off-label communications
- Data source changes – patient experience, RWE and summary data
Click HERE to register!
On Tuesday, President Obama signed the 21st Century Cures Act (the “Act”) into law. The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product development, and health care delivery enterprises. Our colleagues have previously discussed the Act’s many provisions that aim to speed up the process of bringing new drugs and devices to market. One of the Act’s most significant amendments to the Federal Food, Drug and Cosmetic Act will allow FDA to grant accelerated approval to regenerative medicine products, while also providing the Agency with wide discretion on creating new approaches to regenerative medicine. This legislative development is historic given increasing pressure from patients and other stakeholders to move regenerative medicine advancements more quickly from the lab into the clinic. Continue Reading President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative Medicine
This week, a high-profile FDA hearing sought to receive broad stakeholder input on four draft guidance documents from 2014 and early 2015 that further explain the agency’s views on some of the criteria for the regulation level of Human Cell and Tissue Products (HCT/P) as well as on the scope of the “same surgical procedure” exception under 21 CFR § 1271.15. More than 150 people attended in-person, including our own Joanne Hawana, with another 500 webinar attendees. Continue Reading FDA Concludes Two-Day Public Hearing on Human Cell and Tissue Product (HCT/P) Regulatory Paradigm
Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on various regulated products. There was no shortage of significant Agency actions in 2015 related to therapeutic and diagnostic products, which include traditional chemical drugs, biological products, medical devices and diagnostic tests, and even stem cell therapies and human tissue products. Also noteworthy is that FDA is reporting that as of December 14th it had granted approval to 42 groundbreaking new drugs (called “new molecular entities” or NMEs) and therapeutic biological products during the calendar year. The figure so far for this year beats 2014’s final count of 41 approved NMEs and far exceeds the prior year’s total of 27 NMEs. This post will highlight some of FDA’s significant actions this year and provide our thoughts about what next year may bring for FDA-regulated entities.
Continue Reading FDA Legal and Regulatory – 2015 Year In Review