| Call Number (LC) | Title | Results |
|---|---|---|
| HE 20.4702:IM 7 | Guidance for industry Q3A impurities in new drug substances. | 1 |
| HE 20.4702:IM 7/2 | Guidance for industry Q3B(R2) impurities in new drug products. | 1 |
| HE 20.4702:IM 7/3 | Guidance for industry Q3C impurities, residual solvents. | 1 |
| HE 20.4702:IM 7/4 | Guidance for industry ANDAs, impurities in drug products. | 1 |
| HE 20.4702:IM 7/5 | Guidance for industry ANDAs, impurities in drug substances. | 1 |
| HE 20.4702:IM 7/6 | Guidance for industry NDA's : impurities in drug substances. | 1 |
| HE 20.4702:IM 9 | Guidance for industry immunotoxicology evaluation of investigational new drugs. | 1 |
| HE 20.4702:IM 72001 | Guía de la FDA para el importador de alimentos enlatados de ácido bajo y acidificados | 1 |
| HE 20.4702:IN 3/2 | Guidance for industry information program on clinical trials for serious or life-threatening diseases and conditions. | 1 |
| HE 20.4702:IN 3/DRAFT | Guidance for industry influenza, developing drugs for treatment and/or prophylaxis. | 1 |
| HE 20.4702:IN 4/DRAFT | Guidance for industry metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products; chemistry, manufacturing, and controls documentation. | 1 |
| HE 20.4702:IN 8 | 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 20.4702:IN 8/2 | Guidance for industry integrated summaries of effectiveness and safety : location within the common technical document. | 1 |
| HE 20.4702:IN 8/3 | Guidance for industry IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer. | 1 |
| HE 20.4702:IN 8/4 | Guidance for industry INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information. | 1 |
| HE 20.4702:IN 8/5 | Guidance for industry, investigators, and reviewers exploratory IND studies. | 1 |
| HE 20.4702:IN 8/6 | Guidance for industry IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information. | 1 |
| HE 20.4702:IN 8/7 | Guidance for industry, q & a content and format of INDs for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products. | 1 |
| HE 20.4702:K 55 | Los niños no son simplemente adultos pequeños las medicinas, los niños, y el cuidado que todo niños se merece. | 1 |
| HE 20.4702:L 11 |
La nueva etiqueta de los alimentos Guidance for industry clinical lactation studies; study design, data analysis, and recommendations for labeling. |
2 |
