Business · 18/11/1997

FDA Publishes Guidance on Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

The FDA is publishing a guidance document titled 'S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals,' which was developed under the International Conference on Harmonisation, to provide general principles for designing preclinical safety evaluation programs for biopharmaceuticals, effective November 18, 1997, and open for written comments at any time.