REGULATORY ARTICLES

  • New Therapies Require A New Approach To Regulatory Interactions — A Discussion With bluebird bio’s Scott Cleve

    bluebird bio's Scott Cleve recently sat down with The Business of Biotech to talk about shifting regulatory standards and how pharmas can adapt how they engage with regulators.

  • Apply For A Breakthrough Therapy Designation (And Win It!)

    In a recent episode of The Business of Biotech, GlaxoSmithKline's Dr. Ira Gupta and Gilead Sciences' Dr. Shanthi Ganeshan break down breakthrough designations, winning them, and bouncing back from rejection.

  • How To Prepare For A Remote Regulatory Inspection

    Remote regulatory inspections were a significant change that occurred during the COVID-19 crisis. Considering these will continue even after the pandemic, we’ve compiled some tips on how to prepare and what to expect from a remote inspection.

  • Is The FDA About To Reclassify Your Drug Product As A Device?

    Until Oct. 8, 2021, the FDA is seeking public comment on its plans to transition some drugs to device status. The agency's intended implementation will affect not only new products meeting both drug and device statutory definitions in connection with the approval process but also existing products on the market that may have been improperly classified as drugs.

  • Cell And Gene Therapies: Solving Six Challenges

    This past year has seen remarkable progress in the growth of cell and gene therapies. While advances in cell reprogramming, genetic editing, and manufacturing mean affordable cell and gene therapies for a range of diseases and uses, the go-forward path will require planning around these six major issues.

  • CMS Restructured The CAR-T DRG – What It Means For Manufacturers & 4 Strategies Forward

    In August 2021, the Centers for Medicare and Medicaid Services (CMS) expanded the chimeric antigen receptor T-cell (CAR-T) diagnosis-related group (DRG). While industry generally views this change as a positive development, significant uncertainties remain as to the specific immunotherapies included and how payment will change over time. To prepare, you should adjust your launch strategies.

  • Biotech Patenting: 4 Tips & Personal Experiences

    When you file for patent protection for your discoveries, keep these 4 tips in mind. I also share some of my personal experiences with patenting from over the course of the last 28 years, from when I cofounded 180 Life Sciences through now.

  • FDA's Final Rule On Intended Use For Drugs & Devices

    On Sept. 1, 2021, the FDA’s final rule on intended use for drugs and devices became effective. The rule has a complicated history and has been the subject of controversy over the last 6 years. It provides clarity to manufacturers, but many remain dissatisfied with the evidentiary standard for determining intended use. Might legal challenges follow?

  • FDA’s Evolving Regulatory Stance For SaMDs, Wearables, Digital Health & DTx

    In addition to discussing how the FDA has evolved its approach to SaMDs, wearables, digital health, and digital therapeutics over the last couple of years, this article also specifies what can you do to influence future regulations on such devices.

  • How To Find & Manage Biotech Consultants Effectively

    The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.