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)