Breakthrough Designation means designation of a drug as a breakthrough therapy by the NMPA.
Breakthrough Designation means the designation of a drug as a breakthrough therapy by the FDA pursuant to Section 506(a) of the Federal Food Drug and Cosmetic Act (21 U.S.C. §356(a)), as amended by Section 902 of the Food and Drug Administration Safety and Innovation Act and as may be amended further from time to time.
Breakthrough Designation means, with respect to a Product, that such Product satisfies the requirements for a “breakthrough therapy”, as set forth in 21 U.S.C. § 356, as amended by § 902 of the Food and Drug Administration Safety and Innovation Act.
More Definitions of Breakthrough Designation
Breakthrough Designation means designation by the FDA as a breakthrough therapy pursuant to 21 U.S.C. section 356 (or its successor).
Breakthrough Designation means a drug as defined by FDASIA Section 902 that: (a) intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and (b) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development;
Breakthrough Designation means a designation by the FDA of a drug as a breakthrough therapy as set forth in 21 U.S.C. § 356(a) and related FDA guidance, and equivalent rules, regulations and guidance outside of the United States, for example, PRIority MEdicine designation granted by EMA.
Breakthrough Designation means a Compound has received “breakthrough therapy designation” by the FDA as contemplated by Title IX of the United States Food and Drug Administration Safety and Innovation Act of 2012.