particularly when a patient receives a drug from multiple manufacturers. The FDA sets strict standards for the approval of generic equivalents, as do other western countries. Generics must contain ...
An Abbreviated New Drug Application (ANDA) is an application submitted to the U.S. FDA to demonstrate that a generic drug is equivalent to a previously approved Reference Listed Drug (RLD) in terms of ...
Some of China’s senior doctors are raising concern over the quality of domestic generic medicines that have largely replaced western brand-name drugs at hospitals, amid a rare public backlash ...
The RS ensures that generic drugs meet therapeutic equivalence standards ... EMA: Accepts comparator products approved in the EU or equivalent stringent markets. 3. WHO: Permits comparator ...