Browsing Revista Politechnê by Author "Morales Morales, José A."
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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 (Polytechnic University of Puerto Rico, 2010)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 ...