Call Number (LC) | Title | Results |
---|---|---|
HE 20.4702:T 34 | Guidance for industry available therapy | 1 |
HE 20.4702:T 35 | Piénselo muy bien una guía para el control de los beneficios y riesgos de las medicinas | 1 |
HE 20.4702:T 62/DRAFT | Guidance for industry labeling guidance for OTC topical drug products for the treatment of vaginal yeast infections (vulvovaginal candidiasis) | 1 |
HE 20.4702:T 64 | Guidance for industry and review staff recommended approaches to integration of genetic toxicology study results | 1 |
HE 20.4702:T 64/2 | Guidance for industry single dose acute toxicity testing for pharmaceuticals | 1 |
HE 20.4702:T 66 | Guideline for industry detection of toxicity to reproduction for medicinal products, addendum on toxicity to male fertility | 1 |
HE 20.4702:UN 2/DRAFT | Guidance expiration dating of unit-dose repackaged drugs, compliance policy guide | 1 |
HE 20.4702:V 13 | VAERS sistema para reportar reacciones adversas a las vacunas | 1 |
HE 20.4702:V 23 | Guidance for industry Q2B validation of analytical procedures, methodology | 1 |
HE 20.4702:V 42 | Guidance for industry variations in drug products that may be included in a single ANDA | 1 |
HE 20.4702:V 81 | Guidance for industry Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin | 1 |
HE 20.4702:V 88 | Ensayos voluntarios de tratamientos médicos en clínicas experimentales | 1 |
HE 20.4702:W 24/DRAFT | Guidance for industry warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products, content and format | 1 |
HE 20.4708/2: | The CDER reference guide | 1 |
HE 20.4708:L 62 | Guideline on validation of the limulus amebocyte lysate test as an end-product endotoxin test for human and animal parenteral drugs, biological products and medical devices | 1 |
HE 20.4708:M 34 | Guidance for FDA staff and industry marketed unapproved drugs, compliance policy guide | 1 |
HE 20.4709:M 46 | FDA Medical Library serials holdings list | 1 |
HE 20.4716: | Drugs@FDA | 1 |
HE 20.4801: |
Report to the biologics community Annual report FY ... report from the director |
3 |
HE 20.4801:996 | Center for Biologics Evaluation and Research annual report FY | 1 |