Preparation of New Drug Application (NDA)/Abbreviated New Drug Application (ANDA) Major and Moderate Post-Approval Changes for Parental Drug Products Site Transfer
Robles Vázquez, Wilberto
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Actually, the Food and Drug Administration is the United States Federal Agency responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products that emit radiation. When a pharmaceutical company decides to manufacture a new drug product should submit to the Food and Drug Administration either a New Drug Application or an Abbreviated New Drug Application. After a new New Drug Application or Abbreviated New Drug Application is approved by the Food and Drug Administration, any major, moderate, and/or minor regulatory changes must be reported to the Agency. The Food and Drug Administration Guidance for Industry of Changes to an Approved New Drug Application or Abbreviated new Drug Application Chemical Manufacturing Controls Revision 1 of April 2004 will be evaluated and explain major or moderate changes classification. Based on the rigorous evaluation of the Food and Drug Administration for the pharmaceutical manufacturing companies and the wide variety of different post-approval changes, here is developed a step by step guidance to prepare and report a post-approval change supplement.