2007 IT Manufacturing Vaccination 
FDA Law Blog
AUGUST 21, 2023
FDA did, however, try to identify safety issues through the medical literature and (after 2007 when mandatory safety reporting for OTC human drug products marketed without an approved application became effective) through the adverse event reporting system. Koblitz & Deborah L. More than a few have taken far longer—literally decades.
FDA Law Blog
FEBRUARY 4, 2025
The authors suggested that the developers of such therapies would receive a priority review voucher that they can sell to manufacturers of blockbuster drugs. This time, however, the program, which has helped incentivize the development of dozens of pediatric rare disease therapies since 2012, was not renewed.
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