FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products
- Bethany Hills and Dan Rubin authored an article for Life Science Connect outlining the U.S. Food and Drug Administration’s (FDA) new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data and real-world evidence into clinical research, product... ›
Bioinformatics Patents – Subject Matter Eligibility in 2022
By: Jean Nguyen
The increasing presence of data-driven solutions in the healthcare and life sciences sector is apparent from the rise in numbers of patents and patent applications. The number of published bioinformatics patents and patent applications in the last decade has nearly doubled. Bioinformatics patents face... ›Life Sciences Patent Trends in 2022 – Doctrine of Equivalents
By: Meghan McLean Poon
The Federal Circuit continues to tighten the standards for written description of functional claims, particularly in the biologics realm, which is putting patent applicants in the position of having to pursue narrow claims directed to specific sequences. At the same time, reliance on the... ›3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session
FDLI hosted a virtual Enforcement, Litigation, and Compliance Conference December 9–10, 2021. The session titled Compliance Central with FDA Center Compliance Directors: Presentations and Q&A addressed FDA’s top compliance issues, enforcement priorities, and goals for 2022. The session included presentations from Ann Oxenham (CFSAN),... ›Key Takeaways from FDLI’s Enforcement, Litigation, and Compliance Conference Keynote Address
FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the Consumer Protection Branch in 2021, and highlighted areas of... ›- - FDA, Healthcare
What New FDA Policy Means for COVID Tests and Beyond
By: Stacy Cline Amin
Stacy Amin and Bethany Hills, co-chairs of our FDA Regulatory + Compliance practice, authored an article for Law360 discussing the U.S. Department of Health and Human Services (HHS) withdrawing a controversial Trump administration policy that prohibited the U.S. Food and Drug Administration (FDA) from requiring... › Rescinding the MCIT/R&N Final Rule, CMS Seeks New Approaches for Innovative Technology Coverage
On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule (MCIT/R&N). As we reported in an earlier blog post , CMS first proposed... ›Five Key Takeaways from FDA’s Transparency of AI/ML-Enabled Medical Devices Virtual Workshop
By: Stacy Cline Amin
On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices. The workshop focused on the role of transparency in enhancing the safe and effective use of AI/ML technology in... ›Health App and Device Providers Take Note: Health Breach Notification Rule Enforcement Is Coming
By: Melissa M. Crespo
As the mobile health and connected device market continues to grow at an exponential pace, the Federal Trade Commission (“FTC”) has issued a Policy Statement that emphasizes its commitment to ensuring the protection of sensitive information collected by these apps and devices. On September... ›CMS Proposes to Repeal MCIT Final Rule
Last week, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule (the “Proposed Rule”), which CMS published on January 14, 2021 in the waning... ›