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In draft guidance issued on Wednesday, the US Food and Drug Administration (FDA) explains its approach to therapeutic equivalence (TE) evaluations and the assignment of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

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment

FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence ...
JD Supra

Congress Forces FDA to Evaluate Some ‎‎505(b)(2) Products for Therapeutic Equivalence ‎Listing in ‎Orange Book

For nearly forty years, the Food and Drug Administration (“FDA”) has required applicants seeking approval of “generic” or “branded generic” drugs under section 505(b)(2) of the Federal Food, Drug and ...
RAPS

Marketing Status Notifications: FDA Drafts Guidance

The US Food and Drug Administration (FDA) on Wednesday unveiled new draft guidance to help sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) understand what ...