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 |