'Orange Book' Changes? US FDA Soliciting Comments On TE Codes

The agency wants to know if the second letter in the product equivalence ratings system is helpful and whether changes could make the information more user-friendly.

Generics
The FDA also seeks comments on the potential changes to 'Orange Book' patent listing practices. • Source: Shutterstock

Therapeutic equivalence codes could undergo an upgrade as part of the US Food and Drug Administration’s "Orange Book" modernization project.

FDA officials are soliciting public comments on the well-known “A” and “B” codes, which denote whether a drug is substitutable...

More from US FDA

Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

CAR-T REMS Removal Should Boost Access, But Long-Term Follow-Up, Black Box Remain

 

The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.

PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 

Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

More from Agency Leadership