BOX 2-4

Current Review Elements for New Drug Approval

  • Periodic team progress check-ins

  • Midcycle review meeting

  • Team or subgroup interaction on particular issues

  • Primary review completion

  • Secondary (team leader or branch chief) review

  • Review division director, or higher level, review

  • Consult review input

  • Advisory committee meetings

  • Internal briefings for signatory authority

  • Wrap-up (integration of review, consult, and inspection input)

  • Preapproval safety conference (CDER)

  • Preapproval facility inspections (BLAs)

  • Labeling negotiation

  • Issuance of action letter by PDUFA goal date

numerous leaders and acting leaders, name changes, and reorganizations (GAO, 2006). In recent years, it has also assumed expanded responsibilities, and its pharmacists and safety officers are monitoring more products and conducting more assessments, relying on the array of data sources and technologies described below (FDA and CDER, 2005) (see Chapters 3 and 4 for additional discussion of ODS/OSE and OND functions and relationship).

Drug Promotion and Information

The Division of Drug Marketing and Communication (DDMAC) in ODS/OSE is charged with reviewing sponsor promotional materials. The DDMAC staff of 35 reviews more than 53,000 promotional pieces every year, including print and broadcast direct-to-consumer (DTC) advertising (see Chapter 5 for detailed discussion) and materials prepared for professional conferences and for health care providers. FDA does not have the authority to review or sanction promotional material before launch or release (or to review instructions given by sponsors to their sales force) unless they are voluntarily submitted by the sponsor; it often reviews material after it has been released or broadcast, and it can then require corrective action in letters sent to the sponsor. However, many sponsors submit their promotional material in advance to ensure that they will not encounter regulatory problems later.

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