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41. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 10(R1) : polyacrylamide gel electrophoresis general chapter

42. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 8 (R1) : sterility test general chapter

45. The U.S. government and global health security

47. M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

48. Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff