RAPS

FDA Targets Complex Generic Drugs With New Draft Guidance

FDA Targets Complex Generic Drugs With New Draft Guidance The US Food and Drug Administration (FDA) on Monday kicked off a two-day meeting on modernizing generic drug development and released two new ...
RAPS

FDA’s OGD hears ways to accelerate complex generic development

Pharmaceutical industry officials speaking at a Wednesday workshop on complex generics suggested that the US Food and Drug Administration (FDA) create alternative pathways for assessing bioequivalence ...
CNN

FDA to streamline approvals for generic biological drugs in latest move targeting health costs

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...
STAT

Former FDA commissioner: ‘Cost-cutting’ may undo one of Trump’s best drug pricing achievements

Gottlieb is a senior fellow at the American Enterprise Institute and served as commissioner of the Food and Drug Administration from 2017 to 2019. President Trump often touted during his first term ...
Nasdaq

3 Generic Drug Stocks to Watch Amid Pricing Pressure & Tariff Threats

Generic drugmakers continue to face mounting pressure not only from pricing competition but also from Trump’s push for pharmaceutical import tariffs and the proposed “most-favored-nation” pricing ...