|
KMID : 1142220150100020101
|
|
Regulatory Research on Food, Drug & Cosmetic
2015 Volume.10 No. 2 p.101 ~ p.109
|
|
|
Current Paradigm for Expedited Development of Drugs and Biologics: Breakthrough Therapy Designation
|
|
Shin Yang-Mee
Shon Ji-Hong
Ahn Hae-Young
|
|
|
Abstract
|
|
|
Expedited programs have been developed to enhance the efficiency of drug development and review process especially for drugs that address an unmet medical need in the treatment of a serious or life-threatening condition: priority review, fast tract, accelerated approval and breakthrough therapy designation. Since the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed in to law in 2012, a profound paradigm shift has taken place in the drug development and discovery. FDASIA provides for a new breakthrough designation which is the most recent approach for a drug that treats a serious or life threatening disease or condition and adopts the prior expedited program features collectively. A drug intended for breakthrough therapy designation may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints based on the preliminary clinical evidence. A sponsor of a drug product designated with a breakthrough therapy receives many benefits such as more intensive FDA guidance and communications, and eligibility for all fast track designation features to expedite and facilitate the drug development program. Recently, many requests for the breakthrough therapy designation were received for drugs and biologics in diverse therapeutic areas. However, published statistics showed that only 30% of applications were granted for the designation. In order to be eligible
for the consideration, a candidate drug should be carefully selected to meet the criteria for and benefit from the designation. In addition, the applicant needs to establish a sound scientific strategy to maximize the use of the advantageous program and to generate the required data efficiently and promptly through the close communication
with FDA for the successful outcome.
|
|
|
KEYWORD
|
|
|
Expedited program, Breakthrough therapy, Designation conditions, and Developmental strategy
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|