Major areas covered by the FDA's new drug development blueprint program

Major areas covered by the FDA's new drug development blueprint program

Reconstruction of FDA's Extended Services for Small Businesses: The FDA will establish a small business liaison program and a young business project, respectively, and will establish new partnerships with the US Small Business Administration (SBA).

Establishing Infrastructure to Promote and Support Individualized Drug Development: The FDA will invest in establishing a scientific regulatory system and declare in FDA policy support for the development of emerging areas of personalized medicine.

Create a rapid drug development path for important target therapeutic areas: When an IDA drug used to treat serious illnesses shows outstanding therapeutic effects in the early stages of development, FDA will hold a series of scientific meetings to reach an agreement on the development steps of the drug. Open up rapid approval pathways for promising therapeutic drugs and methods.

Exploring the potential of data collection and information sharing while protecting patient privacy: The FDA is rebuilding its IT and data analysis library and establishing scientific cryptographers to ensure that a large number of complex data sets can be analyzed while protecting patient privacy.

Cultivating the Next Generation: The FDA is designing a new future innovator program to train and train potential candidates. Through training, these innovators gain high-end market skills and experience, which also provides FDA with important external expertise and opinion support.

Reform and rationalize the FDA's regulatory regime: The FDA is reviewing its current regulatory regime to identify and change cumbersome, unclear, outdated, ineffective, and inefficient regulatory requirements.

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