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4. 1. 2. 2 1 Schulman S et al for the RE-COVER Study Group. NEJM 2009 361 2342-52. Page 2 of 10 Review Reviewer s comment This addendum to the clinical review for NDA 22-512 dabigatran for prevention of stroke and systemic embolic events addresses the risk of MI in the RE-LY trial. Throughout this document the term MI refers to a clinical MI. Addendum to Clinical Review for NDA 22-512 Drug Sponsor Indication dabigatran Boehringer Ingelhei...

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What is nda 22 512 form?

NDA 22 512 form is a document used by the pharmaceutical industry to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA). It provides information on the drug's safety, effectiveness, and manufacturing processes.

Who is required to file nda 22 512 form?

Pharmaceutical companies and drug manufacturers are required to file NDA 22 512 form if they intend to market a new drug in the United States.

How to fill out nda 22 512 form?

Filling out NDA 22 512 form requires providing detailed information about the drug, including its chemical composition, clinical trial results, proposed labeling, and manufacturing processes. Companies must follow the FDA's guidelines and provide supporting documentation.

What is the purpose of nda 22 512 form?

The purpose of NDA 22 512 form is to seek FDA approval for marketing a new drug in the United States. It allows the FDA to review the drug's safety, efficacy, and manufacturing quality to ensure it meets regulatory standards before it can be sold to the public.

What information must be reported on nda 22 512 form?

NDA 22 512 form requires reporting detailed information about the drug, including its chemical composition, manufacturing process, pre-clinical and clinical trial data, proposed labeling, and safety information. Companies must also include any known risks or side effects associated with the drug.