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27. International Conference on Harmonisation; guidance on good manufacturing practice for active pharmaceutical ingredients; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2001 Sep 25; 66(186):49028-9. PubMed ID: 12358036 [Abstract] [Full Text] [Related]
34. Clinical quality assurance in the pharmaceutical industry. Donahue JJ. Cancer Treat Rep; 1985 Oct 25; 69(10):1195-7. PubMed ID: 4042098 [No Abstract] [Full Text] [Related]
35. Medical devices; intent to initiate proceedings to establish effective dates of requirement for premarket approval for 31 class III preamendments devices--FDA. Advance notice of proposed rulemaking. Fed Regist; 1989 Jan 06; 54(4):550-2. PubMed ID: 10291347 [Abstract] [Full Text] [Related]
36. Medical devices; review and revision of compliance policy guides and regulatory requirements for refurbishers, rebuilders, reconditioners, servicers and "as is" remarketers of medical devices; request for comments and information; extension of comment period--FDA. Advance notice of proposed rulemaking; extension of comment period. Fed Regist; 1998 Mar 25; 63(57):14390-1. PubMed ID: 10177751 [Abstract] [Full Text] [Related]