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What is the regulatory submission process?

Regulatory submissions are packages of information and data required by a regulatory agency to determine whether a regulated healthcare product may proceed to clinical testing or whether is safe and effective for marketing.

How do you get FDA approved?

FDA Drug-Approval Process. A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring.

Can I write a letter to the FDA?

FDA rules have great impact on the nations health, industries and economy. These rules are not created by chance or in a vacuum. They are formed with the publics help. By law, anyone can participate in the rule-making process by commenting in writing.

What documentation is required for FDA?

What documents should I provide to FDA? You should provide FDA with entry documentation which may include the following: Bill of Lading (BOL), Airway Bill (AWB), invoice, and purchase order.

Can FDA copy records?

FDA may request to access and copy records whenever the requirements of section 414(a)(1) or (2) are satisfied, but requests are most likely to occur when FDA becomes aware of: Reportable food reports, as defined in section 417(a)(2) of the FDC Act [21 U.S.C. 5(a).

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