FDA Pharamacogenomic Biomarker Database

Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labels may contain information on genomic biomarkers and can describe: Drug exposure and clinical response...

FDA Resource for Approved Drug Information

Ever wanted to know the ins and outs of almost every drug approved by the Food and Drug Administration since 1939? By using the Drugs@FDA database, you can search for information about FDA-approved brand name and generic drugs and therapeutic biological products.  The...

FDA Strengthens the Science of Regulatory Safety

In order to keep our competitive edge, the Federal Drug Administration (FDA) is placing increased emphasis on strengthening both the field and application of regulatory science relative to pharmaceutical research, development, review, and post-market surveillance. ...

Precedent-setting Lawsuit: Free Speech vs. Off-Label Drug Promotion

Allergan, the maker of Botox, is suing the federal goverment by asserting that marketing restrictions prevent the company from communicating practical medical information — like patient selection criteria or optimal dosing patterns — to doctors that could reduce the...

Enforced 15-day limit on FDA form 483 responses

Starting 15 September 2009, the FDA began enforcing a 15-day limit on post-inspection responses to an FDA-issued form 483  (Inspectional Observations).   Upon  completion of a facility inspection, the FDA may issue a form 483  to notify an inspected...