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Tag Archives: bioequivalence studies Taj Pharmaceutical

Efforts to advance the development of complex generic drugs

Efforts to advance the development of complex generic drugs

The FDA has issued a statement to promote the development of complex generic drugs to ensure access for patients and healthy drug competition   The FDA has released a statement highlighting practices to improve the development of complex generic drugs in order to promote drug competition and patient access. The FDA Commissioner Scott Gottlieb wrote: […]

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Australia Looks to Improve Generic Drug Authorization Process

Australia Looks to Improve Generic Drug Authorization Process

Australia’s Therapeutic Goods Administration (TGA) announced Thursday that it’s considering a range of options to improve the generic medicine registration process. Chief among those options is TGA’s consideration to allow the use of overseas reference product in bioequivalence studies, as currently the reference product used in such studies must be an existing medicine approved in […]

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Generic drugs not different from originals

Generic drugs not different from originals

LETTERS- The current debate on generic drug use is neither new nor unique to Kenya. Globally, there is a lot of debate and discussion about generic and branded medicines. The question has always been about the authenticity of generic drugs— if they can safely be substituted for the more expensive brand names.   Locally, one […]

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