Drug Delivery FDA Approval Insulin Manufacturing 
Roots Analysis
FEBRUARY 22, 2022
Autoinjector As Emerging Drug Delivery Device. The generic version of EpiPen received the FDA approval in 2018. We observed that many companies have entered this field by in-licensing technologies from other players to establish the necessary expertise required to develop / manufacture autoinjectors.
Camargo
OCTOBER 14, 2020
The FDA has also recently launched the Software Pre-Certification Pilot Program to provide an efficient regulatory framework for developers of SaMD products. In this situation, the timing and content of amendments following tentative approval can be complicated; Camargo can help sponsors navigate the process.
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