FDA Calendar Overview and Tutorial

Written by BioMedReports.Com

Friday, 11 December 2009 08:38

The BioMedReports.com FDA Calendar database includes over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.

The FDA Calendar landing page includes a button - Press here to load the latest updates and data - that must be clicked in order to fill the calendar database with the latest information. From left to right, the columns include (1) Company Name, (2) Ticker, (3) Type (e.g. clinical trial, FDA decision, FDA resubmission, FDA new filing, etc.), (4) FDA Date (this is the estimated or published catalyst date for expected study results, FDA decisions, FDA filings, etc.), (5) Details (this is the most extensive entry which contains a text summary of the entry), (6) Last Update (the time / date stamp for the most recent update for each entry).

Some tips for using the FDA Calendar include the ability to sort the database by each column (other than details), which can be very useful, e.g. sorting by ‘Last Update' column yields all of the most recently updated entries. By default the FDA Calendar database is sorted by date in descending order (with catalyst dates that are furthest in the future listed first). Alphabetical sorts by company name or ticker are useful for finding specific companies in the FDA Calendar while sorting by Type groups pending FDA decisions, clinical trial results, FDA new filings, etc.

The FDA Calendar can also be used to hedge against upcoming binary events for companies held in an investment portfolio by retail or institutional investors and to monitor for competitors that have upcoming FDA decisions or clinical trial results. Click here for the current subscription options at BioMedReports.com, including the ability to sign up for the free email newsletter.

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