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HE 20.4702:T 62/DRAFT Guidance for industry labeling guidance for OTC topical drug products for the treatment of vaginal yeast infections (vulvovaginal candidiasis) 1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HE 20.4702:UN 2/DRAFT Guidance expiration dating of unit-dose repackaged drugs, compliance policy guide 1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HE 20.4702:W 24/DRAFT Guidance for industry warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products, content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