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The FDA cited an outsourcing drug compounder in Arkansas for failure to meet sterile production standards, according to a warning letter from the agency. Read More
Continuing education programs could be a useful tool for sponsors charged with providing training and education under a REMS, according to an agency feasibility study. Read More
An FDA agreement to recognize good management practice reports from eight European countries, will allow the agency to reassign investigators to high-priority areas such as India and China, an official told an FDAnews inspections conference. Read More
The FDA finalized its guidance on developing direct-acting antivirals for chronic hepatitis C, outlining Phase III trial design options, enrollment criteria and safety evaluations for specific patient populations. Read More
Without the credit’s lowering of development costs over the past 30 years, the number of orphan drugs produced in the U.S. would have dropped by one-third. Read More