PDUFA Calendar

PDUFA dates for biotech stocks. Advisory Committee Meeting calendar dates also included. The PDUFA date refers to the date the Food and Drug Administration (FDA) are expected to deliver their decision whether or not a approve a companies New Drug Application (NDA) or Biologics License Application (BLA).

On the PDUFA date the FDA will either:

- issue approval for marketing.

- issue a Complete Response Letter (CRL) - i.e. rejection letter.

Note that most large cap companies do NOT announce PDUFA dates.

Advisory Committee Meetings

An advisory committee provides a forum for public discussion of certain issues regarding the efficacy and/or safety of the drug. The committee will generally vote on the efficacy and safety of the product. The FDA, while not bound by the committee decision, tend to generally ( but not always ) follow the advice given by the committee when making its decision on or before the PDUFA date. An Advisory Committee meeting is generally convened approximately 2-4 months prior to the PDUFA date.

PDUFA dates and Advisory Committee Meeting dates may also be viewed on the BioPharmCatalyst FDA Calendar.