Drugs@FDA

Searchable database of regulatory data maintained by the FDA.  Drugs@FDA offers public access to drug labels, patient information (cf. patient information leaflet), approval letters, medical officer reports, statistical officer reports, and other elements of the drug approval package for drugs approved since 1998.  For drugs prior to this date, a Freedom of Information Act request is necessary to obtain these documents.  A comparable database does not exist for biologics, but similar information is available by searching the “Vaccines, Blood & Biologics” section of FDA’s website.

Drugs@FDA: http://www.fda.gov/drugsatfda

For biologics, look for FDA reviews on the webpage of each individual product. FDA has a webpage that lists of all licensed biologics with supporting documents.