Actually not true from other biopharmas I've follo
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Posted On: 11/02/2017 1:45:06 PM
Actually not true from other biopharmas I've followed. The manufacturing process only has to be done in an approved facility. The actual process does not need approval.
I refer to this:
https://www.fda.gov/Drugs/DevelopmentApproval...090016.htm
The approval process for new drug and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMP. FDA inspectors determine whether the firm has the necessary facilities, equipment, and skills to manufacture the new drug for which it has applied for approval. Decisions regarding compliance with CGMP regulations are based upon inspection of the facilities, sample analyses, and compliance history of the firm. This information is summarized in reports which represent several years of history of the firms.
According to this, I can manufacture drug ABC in a facility that is approved to be sanitary and up to CGMP standards and never reveal the actual process.
Just tossing in a couple sense.
I refer to this:
https://www.fda.gov/Drugs/DevelopmentApproval...090016.htm
The approval process for new drug and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMP. FDA inspectors determine whether the firm has the necessary facilities, equipment, and skills to manufacture the new drug for which it has applied for approval. Decisions regarding compliance with CGMP regulations are based upon inspection of the facilities, sample analyses, and compliance history of the firm. This information is summarized in reports which represent several years of history of the firms.
According to this, I can manufacture drug ABC in a facility that is approved to be sanitary and up to CGMP standards and never reveal the actual process.
Just tossing in a couple sense.
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