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The Bush administration is cautioning critics of the FDA budget to consider the agency’s long-term plans when assessing the fiscal 2008 budget proposal.
A federal inquiry called to determine the adequacy of the FDA’s approval process for generic drugs might be a sign of strong support among lawmakers for legislation proposed last month that would create a clear pathway for follow-on biologics, according to industry sources.
Weeks after congressional leaders convened on Capitol Hill to discuss a bill aimed at stopping anticompetitive agreements between generic and brand drug firms, more legislation has emerged targeting another much-criticized practice — launching authorized generics.
While the climate for drug safety reforms was thought to have improved with Democrats’ takeover of both chambers of Congress, the obstacles remain the same for drug safety legislation recently
introduced by Sens. Chris Dodd (D-Conn.) and Chuck Grassley
(R-Iowa), sources say.
The Centers for Medicare & Medicaid Services (CMS) must strengthen its guidance regarding an exception to Medicaid price-reporting requirements to prevent drug companies’ abuse of that provision, key lawmakers say.
A federal inquiry called to determine the adequacy of the FDA’s approval process for generic drugs might be a sign of strong support among lawmakers for legislation proposed last month that would create a clear pathway for follow-on biologics, according to industry sources.
Weeks after congressional leaders convened on Capitol Hill to discuss a bill aimed at stopping anticompetitive agreements between generic and brand drug firms, more legislation has emerged targeting another much-criticized practice — launching authorized generics.
While the climate for drug safety reforms was thought to have improved with Democrats’ takeover of both chambers of Congress, the obstacles remain the same for drug safety legislation recently introduced by Sens. Chris Dodd (D-Conn.) and Chuck Grassley (R-Iowa), sources say.