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INNOSC Theranostics and
Pharmacological Sciences Pediatric drug regulations in India
Figure 6. Scientific guidelines for the development of pediatric medications
Abbreviations: CHMP: Committee for Medicinal Products for Human Use; EMA: European Medical Agency; FDA: Food and Drug Administration.
7.3.2. US fatal diseases. Before the initial PSP filing, these exchanges
should occur for advancement programs covered by
When it comes to juvenile advancement, the FDA is in PREA. Sponsors of advancement programs covered by
favor of early participation and conversations. These can the BPCA can file a PPSR at any stage of the legislative
start as early as the pre-investigated new drug (IND) phase advancement procedure. WRs can be issued by the FDA
or at the finish of phase I discussions. This is particularly at any point during the product developmental process
valid for medications intended to treat life-threatening or as long as there is enough evidence. There are no costs
Volume 7 Issue 4 (2024) 12 doi: 10.36922/itps.3831
