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After nearly two years, the EMA is formalizing its iterative pathway program that saw six applications progress to formal advice from the agency, according to a report. Read More
The FDA is simplifying the process of developing written procedures for an IRB, providing industry with a comprehensive checklist that satisfies both FDA and HHS requirements. Read More
The EMA is mapping out trial designs for the development of therapies to treat Crohn’s disease, ulcerative colitis and mycobacterium tuberculosis. Read More