The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara.
While regulations for biosimilars work their way through the Food and Drug Administration, state governments are already looking at legislation concerning the substitution of biosimilars for their branded counterparts, according to a legal affairs blog focused on the FDA.
