Neonatal Drug Development Could Benefit From Rare Disease Experience

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.