8 initiatives FDA would pursue under FY 2019 budget

FDA Commissioner Scott Gottlieb, MD, on Tuesday outlined several initiatives the agency would take to improve patient treatments and lower healthcare costs, using resources proposed in its recent budget request.

The budget request seeks to maintain existing agency programs at consistent levels. The document also calls for an additional $400 million to fund various planned initiatives.

Here are eight such initiatives to know.

1. Develop more efficient regulatory pathways to advance drug and biologics manufacturing technologies and promote domestic manufacturing.

2. Create a Center of Excellence on Compounding for Outsourcing Facilities to establish the outsourcing industry as a robust and reliable source for compounded products.

3. Foster more innovation and efficiency in device manufacturing by establishing a voluntary program where devicemakers can receive certification for meeting objective manufacturing and product quality criteria.

4. Advance use of real-world evidence during regulatory evaluations to improve human and animal health, and promote patient safety.

5. Shift regulation of digital health technology to a more efficient and novel framework for reliable post-market oversight. The agency would develop a Center of Excellence on Digital Health to facilitate the change.

6. Develop a platform to more efficiently develop and validate modern science-based principles for new drug development.

7. Boost investments in and innovations of rare disease treatments.

8. Modernize the development and review of generic drugs to increase competition and provide more affordable treatments for Americans.

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