Regulacje i polityka gospodarcza · 22/09/1994

FDA Publishes Final Guideline on Stability Testing of New Drug Substances and Products

The Food and Drug Administration (FDA) has released a final guideline on stability testing of new drug substances and products, developed under the International Conference on Harmonisation, to provide formal scientific principles for stability testing of drugs, primarily benefiting applicants submitting new drug applications for new molecular entities and associated drug products.