New or Revised Guidances to Look for from FDA in Calendar Year 2015

FDA issued a Guidance today entitled “Guidance Agenda: New and Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015”. This document gives us an idea of what is new and what changes we can expect on various issues over the coming year. It is not specific as far the specific changes that are upcoming, but at least it provides direction as to where changes or new advice may be forthcoming from FDA.

Continued Complexity Of A High Profile CRO Data Integrity Case

While it is well recognized that any pharmaceutical company implicated with data integrity issues could have significant impact on its business and survivability, the impact from a similarly implicated CRO would be even greater as it could severely impact all sponsors’ pending and approved products. A case in point is Cetero/PRACS. Lachman Consultants was hired by a number of Cetero’s sponsors in support of these very labor intensive and highly specialized audits and (we are happy to say) successfully completed many audits for affected studies.