Zdrowie i gospodarka · 12.08.2005
Draft Guidance for Industry on Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence; Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance for industry entitled "Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence." FDA is withdrawing the draft guidance because the published methodology limits the submission of scientifically valid information to the agency that may be based on different methodologies. FDA does not want to dictate the scientific approach for developing adequate methods.