RAPS

FDA offers new guidance on therapeutic equivalence evaluations

In draft guidance issued on Wednesday, the US Food and Drug Administration (FDA) explains its approach to therapeutic equivalence (TE) evaluations and the assignment of therapeutic equivalence codes, ...
JD Supra

Skinny Facts May Limit Supreme Court’s Decision in ‘Skinny Label’ Generic Drug Approval Case

The Supreme Court on Jan. 16, 2026, agreed to decide a case about how generic companies can communicate to the market about their products, including whether their product promotion may infringe ...
RAPS

FDA Offers First Major Update to ‘Orange Book’ Website

The US Food and Drug Administration (FDA) on Monday launched an improved web-based version of its publication on drugs approved on the basis of safety and effectiveness, more commonly known as the ...