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.