Worldwide Drug Regulatory Controls — Are They/Will they Become Uniform?

Marsh B. T. : Clinical trials procedures. A summary of requirements in thirty-three countries, J. Int. Med. Res. 2:26–31, 1974.

Crout J. R. : EEC-FDA Cooperation in the Regulation of Drugs, paper presented at the Symposium on the “The Future of the European Economic Community Procedures for the Harmonization of Drug Registration,” June 1, 1979, Rome, Italy.

Idem: Expediting the Drug Registration Process, paper presented at the International Federation of Pharmaceutical Manufacturers Association Symposium on “International Drug Registration,” October 5, 1979, Geneva, Switzerland.

Kartzinel R. : Streamlining of the IND and NDA Process: Realisitc Goals for FDA and Industry, paper presented at an FDA/Industry Workshop, Sandoz Pharmaceuticals, E. Hanover, N.J., December 7, 1979.

International Drug Regulatory Monitor, No. 71, pp. 4–11, April 1979.

Strandberg K. : Mutual acceptance of data and exchange of drag applications between western countries. Standpoint of the regulatory agency, in: The Scientific Basis of Official Regulation of Drug Research and Development, pp. 85–89, de Schaepdryver A. F. editors. Proceedings of a Satellite Symposium of the 7th International Congress of Pharmacology, Ghent, Belgium, July 24–25, 1978, Heymans Foundation, Ghent.

Controlling The Use of Therapeutic Drugs. An International Comparison, Wardell W. M. , ed., American Enterprise Institute for Public Policy Research, Washington, D.C., 1978.

Brisson E. L. : Practices, Problems and Progress in the Bioresearch Monitoring Program, paper presented at the Manufacturers Association, L'Enfant Plaza Hotel, Washington, D.C., November 20, 1979.

Crout J. R. : Excerpts of December 11, 1979 speech at Food Drug Law Institute Educational Conference, Washington, D.C., FDC Reports 41, 12–13, 1979.

Halperin J. A. : Legislative Authority Over Drugs in the United States and International Cooperation in Drug Regulation, paper presented at the First Official Seminar on Legislation for Drugs and Medicines, October 22–23, 1979, Rio de Janeiro, Brazil.

International Drug Regulatory Monitor, No. 79, p. 2, January, 1980.

Ibid.: pp. 17–23.

Wardell W. M. : Are these requirements enough or too much? in: The Scientific Basis of Official Regulation of Drug Research and Development pp. 66–80, de Schaepdryver A. F. , editors. Proceedings of a Satellite Symposium of the 7th International Congress of Pharmacology, Ghent, Belgium, July 24–25, 1978, Heymans Foundation, Ghent.