Search FDA Drug Approval Package Reviews

Search the review documents in FDA's drug approval packages (Drugs@FDA, CDER's NDAs and BLAs): summary reviews, medical (clinical), statistical, clinical pharmacology, chemistry, pharmacology/toxicology, microbiology, cross-discipline and multidisciplinary reviews, with the action letters, labeling and correspondence of the same package, in full text where the PDF has a text layer. Use it for how FDA judged the studies behind an approved drug: the pivotal trials' design, endpoints, analyses, dose selection, and what reviewers accepted or criticized. Find by application number, product (brand or generic name), sponsor, discipline, approval date or words in the text. Each result gives the application, submission, product, sponsor, discipline and approval date. CBER's biologics are in search_cber_approvals. Only packages FDA posted online and Assyro has collected are held (most approvals from the late 1990s on); each search says what is not held, and finding nothing does not show FDA posted no review. Call read_fda_drug_review for the text.