Call Number (LC) Title Results
HE 20.4208/2:Os 7 Guidelines for the clinical evaluation of drugs used in the treatment of osteoporosis. 1
HE 20.4208/2:P 41 Guidelines for the clinical evaluation of drugs to prevent, control and/or treat periodontal disease. 1
HE 20.4208/2:P 95 Guidelines for the clinical evaluation of psychoactive drugs in infants and children. 1
HE 20.4208/2:R 11 Guidelines for the clinical evaluation of radiopharmaceutical drugs. 1
HE 20.4208/2:R 11/rev Guidelines for the clinical evaluation of radiopharmaceutical drugs / 1
HE 20.4208:Ad 9 Guideline for postmarketing reporting of adverse drug reactions, [docket no. 85D-0249] : draft. 1
HE 20.4208:An 8 Guideline for the format and content of the summary for new drug and antibiotic applications. 1
HE 20.4208:An 8/2 Guideline on formatting, assembling, and submitting new drug and antibiotic applications. 1
HE 20.4208:Ar 2 Guideline for the submission in microfiche of the archival copy of an application. 1
HE 20.4208:C 42 Guideline for the format and content of the chemistry, manufacturing, and controls section of an application. 1
HE 20.4208:H 88 Guideline for submitting documentation for the stability of human drugs and biologics. 1
HE 20.4208:H 88/2 Guideline for submitting documentation for packaging for human drugs and biologics / 1
HE 20.4208:H 88/3 Guideline for the format and content of the human pharmacokinetics and bioavailability section of an application. 1
HE 20.4208:In 3 A Guide to information services : DDIR Division of Drug Information Resources. 1
HE 20.4208:M 31 Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances / 1
HE 20.4208:M 31/2 Guideline for submitting documentation for the manufacture of and controls for drug products. 1
HE 20.4208:M 39 Guidelines for drug master file. 1
HE 20.4208:M 56 Guideline for submitting samples and analytical data for methods validation. 1
HE 20.4208:M 58 Guideline for the format and content of the microbiology section of an application. 1
HE 20.4208:N 73 Guideline for the format and content of the nonclinical pharmacology/toxicology section of an application. 1