Call Number (LC) | Title | Results |
---|---|---|
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: | 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. Orange book : approved drug products with therapeutic equivalence evaluations. Approved drug products with therapeutic equivalence evaluations |
4 |
HE 20.4715/2: | Approved drug products with therapeutic equivalence evaluations. | 1 |