This is a legal form that was released by the U.S. Department of Health and Human Services - U.S. Food and Drug Administration on August 1, 2018 and used country-wide. Check the official instructions before completing and submitting the form.
Q: What is Form FDA356H?
A: Form FDA356H is an application used to request approval for marketing a new or abbreviated new drug or biologic for human use.
Q: Who uses Form FDA356H?
A: Pharmaceutical companies and manufacturers use Form FDA356H to seek approval from the FDA to market new drugs or biologics for human use.
Q: What does the form require?
A: The form requires detailed information about the drug or biologic, including its composition, manufacturing process, clinical data, proposed labeling, and more.
Q: What is the purpose of Form FDA356H?
A: The purpose of Form FDA356H is to provide the FDA with the necessary information to evaluate the safety and effectiveness of a new drug or biologic before granting approval.
Q: What is the difference between a new drug and an abbreviated new drug?
A: A new drug refers to a drug that contains an active ingredient that has never been approved by the FDA, while an abbreviated new drug is a generic version of an already approved drug.
Q: What happens after submitting Form FDA356H?
A: After submitting the form, the FDA reviews the application, conducts inspections if necessary, and evaluates the data provided to make a decision on approval.
Q: Is there a fee for submitting Form FDA356H?
A: Yes, there are fees associated with submitting Form FDA356H. The specific fee amount depends on the type of application being submitted.
Q: How long does it take for the FDA to review Form FDA356H?
A: The FDA aims to review standard applications within ten months from the date of submission, but the actual review time may vary depending on the complexity of the application.
Q: What happens if Form FDA356H is approved?
A: If the application is approved, the pharmaceutical company or manufacturer can proceed with marketing the new drug or biologic for human use under the conditions specified by the FDA.
Download a fillable version of Form FDA356H by clicking the link below or browse more documents and templates provided by the U.S. Department of Health and Human Services - U.S. Food and Drug Administration.