Notice of Approval of Original Abbreviated New Animal Drug Application; Pyrantel Pamoate SuspensionStephen F. Sundlof
Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in...
Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. 仿制药申请被称为 “简略申请” 是因为它们基本上不需要临床前资料 动物实验 和临床资料 人体实验 来建立安全性的有效...
Genericdrugapplicationsaretermed"abbreviated"becausetheyaregenerallynotrequiredtoincludepreclinical(animal)andclinical(human)datatoestablishsafetyandeffectiveness.仿制药申请被称为“简略申请”,是因为它们基本上不需要临床前资料(动物实验)和临床资料(人体实验)来建立安全性的有效性。Instead,genericapplicantsmust...
Genericdrugapplicationsare termedquotabbreviatedquotbecausetheyaregenerallynotrequiredtoincludepreclinical animalandclinicalhumandatatoestablishsafetyandeffectiveness.仿制药申请被称为 “简略申请”是因为它们基本上不需要临床前资料动物实验和临床资料人体实验来建 立安全性的有效性。Insteadgenericapplicantsmustscientifically...
animal and clinical trials, but only need to prove that the generic drug and the reference drug (RLD, Reference Listed) Drug) between bioequivalence. The Hatch-Waxman Act has epoch-making significance, and the simplified and new drug application procedures revised accordingly have been used today....
Currently, follow-on biologics are approved or licensed by submitting to FDA a full product license application - either a New Drug Application (NDA) or a Biologic License Application (BLA). Those products that have been approved or licensed are not copies of the original, innovative ...
AAPAktion zur Abschaffung des Primatenhandels(German: Campaign Against Animal Testing) AAPAbbreviated Acquisition Program AAPAzure Applikation Proxy(software) AAPAsbestos Action Program AAPAdvanced Apprenticeship Programme(various companies) AAPAmerican Academy of Poets ...
DOADistributed Objects and Applications DOADate of Assessment(various locations) DOADrug of Abuse DOADepartment of Aviation DOADivision of Aviation(various locations) DOADate of Award DOADepartment of Airports DOADate of Accident(insurance term)
AA Animal Aid AA Acetic Anhydride AA Agent Agreement AA Algorithmic Architecture AA Asian-African AA Administrative Authority AA Action Aid (UK) AA Automated Attendant AA Advanced Airway AA Attack Attack! (band) AA Anxiety Attack AA Air Attache AA Assembly Area AA Audio Adrenaline (band) AA Arit...