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The following is a list of all entries tagged with EWG:
Drug Regulators, FDA CDER, Publish Guidance on ICH Q4B Annex 10 Polyacrylamide Gel Electrophoresis General Chapter for Pharmacopoeial Texts
Filed in manufacturing, May 6, 2010, 7:45 amThis annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions
Drug Regulators, FDA, CDER, Publish Guidance on ICH Q4B Annex 7 Dissolution Tests General Chapter for Pharmacopoeial Texts
Filed in manufacturing, May 5, 2010, 7:41 amhis annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions
Drug Regulators, FDA, CDER, Publish Guidance on ICH Tablet Friability Q4B Annex 9
Filed in manufacturing, May 4, 2010, 7:40 amThis annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions
Drug Regulators, FDA CDER, Publish Guidance on Q4B Annex 8 Sterility Test General Chapter for ICH Regions
Filed in manufacturing, January 8, 2010, 8:35 amThis annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions.
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