The next iteration of the Generic Drug User Fee Amendments program should focus on enhancing communications between the US Food and Drug Administration (FDA) and generic drug applicants, industry ...

Opinions expressed by Digital Journal contributors are their own. Santosh Kesarpu has established expertise in complex generic formulation, applying rigorous science to develop medicines that address ...

FDA Outlines New Communication Process for Generic Drug Companies The US Food and Drug Administration (FDA) is out with its fourth draft guidance document under the 2012 Generic Drug User Fee Act, ...

Off-patent medicines provide people with access to high-quality essential treatment options that can be significantly less expensive than branded on-patent medicines. Off-patent therapies — generics ...

Previous estimates of generic drug development and approval costs cite figures ranging from as low as $250,000 to as high as $25 million (although more recent studies suggest that these values are ...

The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars, which are generic versions of complex biological drugs. These ...

Defining the steps involved in a successful technology transfer process would benefit biopharma, say the researchers behind a “generic” blueprint intended to help drug makers move more easily from ...