I recently noticed that for the approval of the new drugs (NDA) and biological products (BLA), the information about the approval process was published on FDA's website and in very timely fashion. Just a year ago, the FDA review/approval process regarding a new product was still not transparent to the public. We may be able to find some information on label, approval letter, and SBA (summary basis of approval); however, there were typically months or years after the approval.
Now, for the new approvals, not only the label, approval letter, and SBA, but also reviews from different perspectives (medical, statistical, pharmacology, enrivomental, CMC,...) as well as the administrative documents and correspondence between the FDA and the sponsor may be posted on FDA's website. Also listed or published is the list of FDA's officers who participated in the review and the decision making. The individuals from the sponsor's side may also be listed in some documents or correpondence.
This is obviously the outcome of FDA's initiative on transparency. "In June 2009, Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg launched FDA's Transparency Initiative and formed an internal task force to develop recommendations for making useful and understandable information about FDA activities and decision-making more readily available to the public, in a timely manner and in a user-friendly format."
To feel these changes, we can just take a look at two products recently approved by FDA: one by CDER and one by CBER. Don't forget to visit "Administrative Document(s) and Correspondence" or "Approval History, Letters, Reviews, and Related Documents".
This is a good sign that FDA's drug approval process is being demystified and moving to the transparency.