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Compounding status is not the same as FDA approval: Even if a clinic or pharmacy markets a blend, that does not make it an FDA-approved medication

Additionally, we discuss emerging biomarkers, current challenges, and future directions in research

W., Aguilar-Loza, N

Deepa has experience of interacting with various regulators- USFDA, EMA, MHRA, MEB, Health Canada, WHO, TGA for scientific advice, pre-IND meetings, end of phase meetings to discuss clinical development path, clinical trial designs and post marketing commitments including PMS/ Phase IV studies and paediatric investigation plan (PIP)

This still requires a team of professionals to manage the transition of care from the pediatric to the adult setting

Protocols here may help support those foundational processes before moving toward more targeted work