FDA's Center for Drug Evaluation and Research (CDER) has compiled a Data
Briefing from 1996-2006. The report provides a complete overview about FDA's
recent activities in the field of Drug Evaluation and Research. It provides
the number of filings and their median time for approvals for each year and
for various kinds of drugs like NCEs, NBEs, paediatric or Generic.
Other interesting facts are:
- An analysis of 1999-2004 retail sales data from IMS
Health showing how more generic competition lowers drug prices. The
entry of a second generic competitor brings about the largest price
reduction (almost 50%).
- The number of inspections of foreign clinical
investigators has been increasing since 2002 with 95 inspections in
- In FY 2006, FDA field offices conducted 184
pre-approval inspections in support of 81 new drug applications and 109
generic drug applications. 1,329 current good manufacturing practice
inspections have been conducted.
- The number Adverse Event Reports is constantly
increasing and has more than doubled in the review period. Electronic
submission of adverse event reports permits more timely receipt and
evaluation at a considerable cost savings for both the FDA and industry.
As of the end of 2006, 38 sponsors were submitting their 15-day reports
electronically, and seven were submitting their periodic adverse event
- The average monthly use of CDER Internet Site is
growing very fast. There was a 100% increase in hits of the website from
2005 to 2006 up to 53 million hits. An indicator of the still growing
worldwide importance of the agency.
Because of enhanced co-operation among regulators around
the world, the FDA has entered into international agreements. Currently the
agency has international Information-Sharing Agreements with13 foreign
nations, one with EMEA and one with the WHO. The aim is to pursue more open
dialogue on emerging issues as well as exchange routine information on
scientific review, policy development and enforcement.
The document can be found here: