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.
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...
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.
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.
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.
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.
