Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability

7 organizations filed 7 public comments on Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability, at the Food and Drug Administration. The comment window closed 14d ago.

Commenters (7)

• Alliance for Regenerative Medicinetrade assoc.

  1 filing · confidence 85%
• American Society of Gene & Cell Therapytrade assoc.

  1 filing · confidence 85%
• Association for the Advancement of Blood & Biotherapiestrade assoc.

  1 filing · confidence 85%
• Eli Lilly and Companyunverified attribution

  1 filing · confidence 70%
• KROMATID INCunverified attribution

  1 filing · confidence 70%
• Parenteral Drug Associationtrade assoc.

  1 filing · confidence 97%
• Testavec Ltdunverified attribution

  1 filing · confidence 70%