Call Number (LC) Title Results
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HE 20.4702:W 24/DRAFT Guidance for industry warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products, content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: Quick index to general subjects of interest related to drug regulation. 1
HE 20.4708/2: The CDER reference guide 1
HE 20.4708:AN 8 Guidelines for the clinical evaluation of anti-inflammatory and antirheumatic drugs (adults and children) 1
HE 20.4708:C 61 Guideline for the format and content of the clinical and statistical sections of an application / 1
HE 20.4708:D 84 Guidance for industry national uniformity for nonprescription drugs : ingredient listing for OTC drugs. 1
HE 20.4708:El 2 Guideline for the study of drugs likely to be used in the elderly. 1
HE 20.4708:IN 2/2 Guidance for industry : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products. 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 /
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 		2
HE 20.4708:M 34 Guidance for FDA staff and industry marketed unapproved drugs, compliance policy guide. 1
HE 20.4708:M 39 Guideline for Drug Master Files. 1
HE 20.4709:M 46 FDA Medical Library serials holdings list / 1
HE 20.4715: Approved drug products with therapeutic equivalence evaluations
Approved drug products with therapeutic equivalence evaluations.
Orange book : approved drug products with therapeutic equivalence evaluations. 		4
HE 20.4715/2: Approved drug products with therapeutic equivalence evaluations. 1
HE 20.4716: Drugs@FDA 1
HE 20.4717: News along the pike 1
HE 20.4801 Annual report 1
HE 20.4801: Annual report
Report to the biologics community
FY ... report from the director. 		4