FDA CDER Publishes Facts-and-Figures Document

GMP News
19 September 2007

FDA CDER Publishes Facts-and-Figures Document

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 2006.
  • 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 reports electronically.
  • 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:

Learn more about FDA inspections and related topics in the following ECA course:

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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