24.Dec, 2019 0

Comparing FDA non-approval letters, and the press releases from sponsors

Read the full open access research: http://www.bmj.com/content/350/bmj.h2758 When the US Food and Drug Administration (FDA) declines to approve an application to market a drug, it informs the sponsor (the drug company) sin a complete response letter. These letters systematically document deficiencies that FDA reviewers have identified and typically explain corrective…