'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.
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Commissioner says agency will modernize drug patent reference manual this year and consider potential changes to Orange Book administration policy. However, any transformative moves could trigger a court challenge.
Six months after submission deadline, about one-third of one-time marketing status reports have been reviewed, agency says.
US agency is seeking feedback from interested stakeholders about administrative steps it can take to better promote generic competition; July 18 meeting will involve only presentations from the public.