Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry
Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1). These recommendations pertain to the format of content […]
Bladder Cancer Developing Drugs and Biologics for Adjuvant Treatment
Bladder Cancer Developing Drugs and Biologics for Adjuvant Treatment guidance provides recommendations to sponsors regarding the development of drugs and biological products regulated by CDER and CBER for the adjuvant treatment of muscle-invasive bladder cancer. The guidance includes recommendations regarding eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free […]
Instructions for Use Patient Labeling for Human Prescription Drug and Biological Products Content and Format
Instructions for Use Patient Labeling for Human Prescription Drug and Biological Products Content and Format guidance provides recommendations for developing the content and format of a patient Instructions for Use (IFU) document for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or […]
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
Size, shape and other physical attributes of generic tablets and capsule provide the information to the manufacturers. Tablets and capsules are widely manufactured and prescribed and may provide a number of advantages over other dosage forms, including ease of storage, portability, ease of administration, and accuracy in dosing.
Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products
Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products document provides guidance regarding good manufacturing practice for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are […]
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials purpose of this guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards with information to facilitate the inclusion of adolescent patients (for purposes of this guidance, defined as ages 12 to 17) in relevant adult oncology clinical trials. The […]
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products purpose of this guidance is to assist industry in developing enrichment strategies that can be used in clinical investigations intended to demonstrate effectiveness (and in some cases safety) of human drugs and biological products. This guidance defines several types of enrichment […]
Humanitarian Use Device (HUD) Designations
Humanitarian Use Device (HUD) Designations guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD) designation requests to the U.S. Food and Drug Administration’s (FDA or Agency) Office of Orphan Products Development (OOPD). It is also designed to assist FDA reviewers in their evaluation and analysis of HUD […]
Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry
Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry document provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a […]