#6: Expedited Programs for Serious Conditions – Drugs and Biologics
December 8, 2016
In May 2014, the FDA published a guidance document entitled “Expedited Programs for Serious Conditions – Drugs and Biologics.” The intention of the document was to provide drug makers with an incentive to develop products that fill unmet medical needs for serious conditions. Since its publication, the program established by the guidance document has become an increasingly popular pathway for many companies developing new drug products.
Do you think your product may fall into the category of drugs covered by this incentive program? Are you seeking expedited approval for an applicable drug product? We can help you achieve a successful interaction with FDA. To learn more about our services and capabilities, contact us today.
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What is the Drug Supply Chain Security Act (DSCSA)?
Update: The FDA has recently granted a one-year extension until November 27, 2024, for the enforcement of system-wide electronic interoperable systems that track products throughout the supply chain....