Exploring The Future Of Generics

October 21-23, 2024 | Rockville, Maryland GRx+Biosims 2024 is the leading scientific, regulatory, and policy event for the U.S. ...

40% of

FDA discusses topics in cutting edge science in complex

This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment ...

... medicines available How Ascend competes in a crowded industry Watch now to understand the

Are less-expensive

Gaps in how the U.S. Food and Drug Administration evaluates the safety of

Scathing criticism is arising from leading doctors about the soaring cost of generic prescription drugs.

This workshop focused on common issues seen in abbreviated new drug applications (ANDAs), link GDUFA science and ...

GRx+Biosims™ 2025 is the leading regulatory science and policy event for the U.S.

12 years ago, Investigative Journalist Katherine Eban received a phone call that would be the start of the investigation of a lifetime ...

The next patent cliff: A reality….or just the injectable/biologics players pushing medicines out of reach of 'most'

The purpose of this public workshop is to communicate how FDA's

For most products, “Made in the USA” is a point of pride. For medicine, it may be about safety. After months of investigating drug ...

India has long been known as the pharmacy of the world—but is that identity enough for the

Presenters and a panel discuss leveraging model integrated evidence for long-acting injectables (LAIs) to reduce regulatory ...

This public workshop communicated how FDA's

Presenters and a panel discuss

Generics

FDA experts demonstrate the FDA's