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Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more
The Spanish Agency for Medicinal Products and Medical Devices (AEMPS) stated that it will not take, for the time being, any regulatory action to temporarily suspend or halt the recruitment of patients for clinical trials to...more
On November 19, 2018, the U.S. Department of Health and Human Services, Office for Human Research Protections (“OHRP”) announced the availability of additional draft guidance related to a new exclusion from regulatory...more
On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). ...more
Ongoing Effort to Harmonize Human Subject Research Regulations The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services (HHS),...more
The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more