Last week, FDA launched Drug Trials Snapshot, a pilot program intended to provide consumers with information about the sex, age, race and ethnicity of clinical participants for six drugs approved in May and June 2014. This pilot is intended to solicit feedback on the content, format and usefulness of the information provided in advance
FDASIA
Be Prepared Before FDA Inspectors Come Knocking: New Guidance
By Shilpa Prem on
Posted in FDA
Late last month, the FDA finalized a new guidance document, explaining the agency’s current thinking on the circumstances that may arise in connection with an establishment inspection that it would consider to impose an inappropriate limitation on its inspection authority. The Food and Drug Administration Safety and Innovation Act (FDASIA) deems a drug or…