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Drug Master Files Guidance for Industry
12 FDA is developing a form to replace the cover letter used for original and subsequent submissions. The form 486 including floor plans, can be
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21 CFR 1313.35 - Return declaration or amendment to Form
1313.35 Return declaration or amendment to Form 486 for international transactions. (a) Within 30 calendar days after an international transaction is
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DEA Form 486
RETURN DECLARATION (Name Quantity of List I and List II Chemical Distributed to the Transferee. MUST be returned within 30 days from actual date of import (8d)
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