PDUFADATE.com has been developed to provide information that is relevant to the progress of a drug or biological through the US regulatory process. While the major focus is on providing a single, easy to read listing of PDUFA Dates as provided by sponsors, we recognize that this alone is merely a milestone and additional information is valuable to the reader in determining the progress and likely outcome of a drug or biological through the regulatory process. These additional milestones include progress through Phase II and Phase III clinical development, information that may be available from the sponsor about the outcome of meetings with the FDA, announcements about NDA or BLA submissions or major Amendments to existing approvals, scheduled FDA Advisory Committee meetings, and Complete Response letters from the FDA on pending applications.
PDUFADate provides multiple levels of information for our clients, all through our website www.PDUFADate.com. The first level is available to the public and is a listing of all of the compounds that Pharma companies are reporting as having completed Phase III clinical trials and/or for which applications have been submitted to the FDA and are under active review. Where available from the sponsor, we have provided the current PDUFA Date.
The second level of information available for clients will be by subscription. This will include all of the information from level 1 but it will include additional information from the sponsor such as a scheduled Advisory Committee meeting, the results of the Advisory Committee if it has already taken place, information about any communications that are available from the FDA such as a Complete Response letter and the contents of such a letter. This second level will also contain information from the sponsor about pending applications for the listed drug if the application has not yet been submitted, or the availability of data necessary to complete a response to the FDA or to make an application.
The third level of information available to our clients will include all of the information from levels 1 and 2 plus a regulatory analysis if necessary about pending FDA actions, such as our interpretation of the likely outcome of a scheduled Advisory Committee or the interpretation of an Advisory Committee vote, or an interpretation of the contents of a Complete Response Letter. In addition, other events which are indirectly related to an application under review by the FDA will be discussed with an eye towards impact on any pending application. All information will be archieved following final action by the FDA. Clients with access to Level 3 will have access to all archived information.
The fourth level of information available to our clients will include all of the information in the first 3 levels cited above, and the ability to have direct access to PDUFADate.com staff for queries and or discussion of our interpretation of pending activities. This could be in the form of an open forum to discuss for example our interpretation of an upcoming Advisory Committee or the contents of a Complete Response Letter. These discussions generally would not include the drug sponsor as a participant as this would jeopardize the proprietary nature of their submission. Our staff would be available for private discussions with an specific sponsor on a fee for service basis.
We also recognize there may be a need for tutorials on certain aspects of the regulatory process. These will be developed and made available on the website.