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ConfidentialClinical Policy: Buprenorphine Injection (Brigade) Reference Number: CP.PAR.498 Effective Date: FDA Approval Date Last Review Date: 08.21 Line of Business: Commercial, HIM, MedicaidCoding
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Visit the FDA website and navigate to the submissions page.
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Select the appropriate form for submitting the new product information.
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Fill out all required fields on the form, including information about the product, its intended use, and any supporting data or documentation.
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Braeburns or any pharmaceutical company seeking approval for a new product from the FDA would need to fill out and submit the necessary forms for acceptance.
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Fda accepts braeburns new refers to the FDA approving a new drug or medical device called braeburns.
The manufacturer or sponsor of the new drug or medical device is required to file for FDA acceptance.
The manufacturer or sponsor must submit the necessary documentation and data to the FDA for review.
The purpose is to ensure that the new drug or medical device is safe and effective for use in the market.
The documentation must include clinical trial data, safety information, and manufacturing details.
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