FDA's Generic Policy Initiative Includes Choose-Your-Own-Agenda Meeting
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.
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FDA Grant Establishes Complex Generics Center To Increase Access
Complex active ingredients, formulations, routes of delivery, and drug-device combination products are to receive greater attention as part of attempts to facilitate competition after the US FDA awarded a $5m grant to establish a dedicated research center.
FDA Asks For Input On Therapeutic Equivalence
The FDA wants to know if the second letter in its product equivalence ratings system is helpful and whether changes could make the information more user-friendly.
'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.