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NDA 210933 NDA APPROVAL Gala Pharmaceuticals, Inc. Attention: Patrick Foster Senior Director, Regulatory Affairs 490 Arsenal Street Suite 120 Watertown, MA 02472 Dear Mr. Foster: Please refer to your
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NDA 210933 approval is the process of reviewing a New Drug Application (NDA) by the FDA to determine if a new drug should be approved for marketing in the United States.
The pharmaceutical company developing the new drug is required to file NDA 210933 for approval.
NDA 210933 should be filled out with detailed information about the new drug, including its safety and efficacy data, manufacturing processes, and proposed labeling.
The purpose of NDA 210933 approval is to ensure that new drugs marketed in the US are safe and effective for their intended use.
NDA 210933 must include preclinical and clinical data, drug labeling, manufacturing information, and proposed risk management plans.
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