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The FDA issued a draft guidance for trials of hormonal birth control products that makes recommendations regarding enrollment criteria, study elements, and safety and efficacy considerations. Read More
The FDA issued draft recommendations for drug developers on how to make the best use of the agency’s online database of inactive ingredients. Read More
The main purpose of an IFU is to provide “detailed, action-oriented, step-by-step written and visual instructions in a patient-friendly manner,” the agency said. Read More
Approximately half of children and adults with the condition go on to experience fibrosis, cirrhosis or liver transplant within three years of the disease’s onset. Read More