DMD In The Spotlight
The FDA draft guidance for Duchenne’s muscular dystrophy drug development, which advocacy groups tried to push through to make sure the agency understood the complications of getting some of these drugs approved, is a good example of stakeholder interaction in the rare disease space.
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For larger organizations with interests in rare diseases, Bionest Partners believes it is necessary to maintain a separation from the rest of the company in order to keep the culture needed for successful product commercialization. Easier said than done.
FDA wants another clinical trial for Duchenne muscular dystrophy treatment; focus moves to Sarepta's candidate, which gets committee review next week.
While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.