Guidance Calendar from FDA

The FDA today released its Guidance Calendar for 2009.  It is perhaps as interesting for what is not on the calendar as it is for what is on the calendar.

Many Med/Reg people long for guidance from the FDA on the use of digital media.  Such a guidance is doubtful for many reasons – the primary one of which is that existing guidances are sufficient.  However, for those hoping for such a Guidance, chances have grown dimmer.  Under the category of Advertising, the only Guidances scheduled are:
  • Amendment of the Brief Summary                                                                                                         
  • Presentation of Risk Information in Prescription Drug and Medical Device Promotion 

The latter is certainly handy due to the fact that so many Warning Letters have been issued this year because of the lack of risk inclusion in marketing materials.  

Other Guidance documents that will be interesting include:
  • The design of adaptive clinical trials – this could provide companies with alternatives and less costly means of testing drugs;
  • Immunogenicity assessment for therapeutic protein products – this could have a defining influence on the development of follow-on-biologics, particularly if devised prior to a regulatory pathway design from Congress;
  • Non-inferiority trials – a growing issue for drug makers and which could influence reimbursement decisions; 
  • Best Practices for Conducting Pharmacovigilance Studies Using Electronic Healthcare Data – particularly with the potential for huge investment by the Administration in Health IT, this is particularly timely.  

There are many others of interesting, including ones on proper labeling and naming and on Dear Doctor letters.  Check out the list.    

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After publication at 10:52 AM, this posting was amended at 12:11 PM with the following
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By the way, the FDA is not bound to act on any of these and many of these topics have been on the FDA's Guidance Document calendar for years.  But with a new Administration and a new FDA Director, who knows?
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