Friday, January 20, 2017

the 21st Century Cures Act: Key Provisions

Last week and this week, Hyman, Phelps &McNamara, P.C. gave two excellent webinars to explain the key provisions from the 21st Century Cures Act

The first webinar is about 'Pharmaceutical & Biologics Provisions'. The webinar can be replayed here. The webinar discussed top 13 pharmaceutical & biological issues listed below: 
  • Patient Experience Data (Section 3001)
  • Patient-Focused Drug Development (Sections 3002-3004)
  • Qualification of Drug Development Tools (Section 3011)
  • Priority Review Vouchers (Sections 3013, 3014, & 3086)
  • Human Research Protections (Sections 3023 & 3024)
  • Expanded Access Policies (Section 3032)
  • Limited Population Pathway (Section 3042)
  • Health Care Economic Information (Section 3037)
  • Real World Evidence (Section 3022)
  • Regenerative Advanced Therapies (Sections 3033-3036)
  • Hiring Authority (Section 3072)
  • Targeted Drugs for Rare Diseases (Section 3012)
  • Novel Clinical Trial Designs (Section 3021)


The second webinar is about ‘Combination Products andMedical Device Provisions’. The webinar can be replayed here. The following 11 provision topics were discussed.
  • Combination products (Sec. 3038)
  • Breakthrough devices (Sec. 3051)
  • Humanitarian device exempt. (Sec. 3052)
  • Recognition of standards (Sec. 3053)
  • 510(k) exemptions for Class I/II devices (Sec. 3054)
  • Classification panels (Sec. 3055)
  • Institutional review board (IRB) flexibility (Sec. 3056)
  • CLIA waiver improvements (Sec. 3057)
  • Least burdensome device review (Sec. 3058)
  • Cleaning instructions and validation (Sec. 3059)
  • Clarifying medical software regulation  (Sec. 3060)


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