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FDA Targets Complex Generic Drugs With New Draft Guidance

FDA Targets Complex Generic Drugs With New Draft Guidance The US Food and Drug Administration (FDA) on Monday kicked off a two-day meeting on modernizing generic drug development and released two new ...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

The US Food and Drug Administration (FDA) has published a manual of policies and procedures (MAPP) outlining how the Office of Generic Drugs (OGD) will classify which new drugs and drug-device ...
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 ...
Business Wire

Ambio Announces US FDA Approval of a Generic Version of Forteo® (Teriparatide Injection) for Its Partner Apotex

BEECH ISLAND, S.C.--(BUSINESS WIRE)--Ambio, Inc., an innovative biotech company developing novel peptide drugs, biosimilar, bioequivalent, and other complex generic drugs, announced today that a ...