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…
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Bladder Cancer Developing Drugs and Biologics for Adjuvant Treatment guidance provides recommendations to sponsors regarding the development of drugs and biological products regulated by…
Read more →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…
Read more →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…
Read more →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…
Read more →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,…
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