Talking It Out: Perseverance Helps Sponsors Overcome Disagreements With FDA
Some of the most valuable lessons from the Drug Review Profile series involve getting FDA to be flexible about what kind of clinical data it requires.
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Pharmaceutical manufacturers and FDA have enthusiastically embraced the “breakthrough therapy” program as a way to more quickly bring new drugs with substantial effects to patients in need. With two years of program experience now under their belts, agency and industry representatives talk about learnings and best practices that could be applied to the development and review of drugs outside the program.
FDA’s use of REMS continues to fall to almost undetectable levels, with the agency using the safety tools just a handful of times in the sixth full year of the program. REMS are now very much the exception and not the rule for new products – but still a very important exception.
The miss on improving castration resistance-free survival in Phase III trial is not likely to affect the ongoing FDA review, the company and analysts agree.