RAPS

FDA updates guidance on generic drug development during COVID

The US Food and Drug Administration (FDA) on Wednesday revised its questions and answers guidance on generic drug development and abbreviated new drug application (ANDA) submissions during the ...

Sorensen drug-pricing bill draws criticism from former FDA official

Sorensen recently reintroduced the bipartisan STOP GAMES Act, legislation aimed at preventing what he describes as "sham" ...
Hosted on MSN

FDA to streamline approvals of generic biologic drugs

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...
Health Affairs

Unlocking The Full Potential Of Generic Drugs For Patients

Generic drug repurposing is an underused but promising tool for finding new, affordable therapies. Creating a pull incentive can spur developers to finally explore the untapped potential in these ...
RAPS

FDA offers guidance on generic drug development during COVID

The US Food and Drug Administration (FDA) on Monday released a new questions and answers guidance for generic drugmakers addressing generic product development and abbreviated new drug application ...