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Drug Submission Application Fee Form for Human and Disinfectant Drugs1. MANUFACTURER/SPONSOR AND DRUG PRODUCT INFORMATIONPRODUCT Product Name as per Drug Submission Application form (item 8): MANUFACTURER/SPONSOR
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Drug submission - application is the process of submitting a request to authorize the sale or marketing of a new drug by a regulatory agency.
Any pharmaceutical company or drug manufacturer looking to market a new drug is required to file a drug submission - application.
To fill out a drug submission - application, companies must provide detailed information about the drug's safety, efficacy, manufacturing process, and any potential side effects.
The purpose of a drug submission - application is to demonstrate to regulatory agencies that a new drug is safe and effective for use by the general public.
Information such as preclinical and clinical trial data, manufacturing process details, labeling and packaging information, and any potential risks or side effects must be reported on a drug submission - application.
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