Summary of the 34th annual meeting of the Drug Information Association.
A variety of issues relating to clinical aspects of drug development were discussed at the 34(th) annual meeting of the Drug Information Association. Among the topics covered at this conference were the following: 1, development of CNS compounds; 2, the Common Technical Document (CTD); and 3, labelling of drugs for use in pregnancy. Issues surrounding the development of CNS compounds were discussed by regulatory authorities from the USA and Europe. In almost all aspects covered, the regulatory requirements for approval in Europe appear to be consistent with those in the USA. Efforts aimed at developing a CTD are ongoing under the auspices of the ICH. The goal of this effort is to develop a common technical information package that can be submitted to regulatory authorities in the USA, the EU and Japan. It is recognised, however, that a number of sections of regulatory submissions will remain outside of the CTD. New initiatives in the labelling of drugs for use in pregnancy in the USA were reviewed. These efforts are being led by the Pregnancy Labeling Task Force of the USA FDA. The overall goal of this effort is to more clearly define by labelling, the relative risks of pharmaceutical agents that must be administered to pregnant women.
Heydorn
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Synaptic Pharmaceutical Corporation, Paramus, NJ 07652, USA. wheydorn@synapticcorp.com