Pharmaceutical Executive October 21, 2021
FDA is expanding its Emerging Technology Program (ETP) and providing more support for new drug applications (NDAs) that present advanced manufacturing technologies, but the agency and industry face key challenges in advancing these initiatives.
In its ongoing campaign to encourage industry adoption of more efficient and reliable pharmaceutical production methods, FDA is expanding its Emerging Technology Program (ETP) and providing more support for new drug applications (NDAs) that present advanced manufacturing technologies. While these initiatives aim to limit drug shortages and recalls due to quality issues, the program also seeks to expand investment in domestic production to enhance access to critical therapies and vaccines for U.S. patients. At the same time, the agency is collaborating with foreign regulatory authorities to...
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