Relief Therapeutics Holding AG (RLFTF)

[changes_iv]

LONG LIVE Zyesami (TM) ~ Aviptadil ~ RLF-100…Shukransaid???

While such endpoints may get drugs to the market more quickly, they must still meet the same standards for safety and efficacy as their traditionally approved counterparts (substantial evidence based on adequate and well-controlled clinical investigations). The difference is that drugs granted accelerated approval must promptly conduct post-marketing confirmatory trials to verify the clinical benefit (as early as underway at the time the marketing application is submitted).[11]

Sponsors considering accelerated approval should discuss their drug development program with the reviewing division at the earliest stages of development. Among other concerns, accelerated approval will necessarily dictate a more rapid pace for other aspects of the development program such as CMC [Chemistry, Manufacturing & Control] or development of necessary companion diagnostics.[12]

https://pharmdevgroup.com/fda-expedited-programs-explained/