FDA, Industry Reach Agreement On Major Portions Of Generic User Fee Program
This article was originally published in The Pink Sheet Daily
Pending agreement includes a one-time fee for ANDA applications in the backlog.
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Bangladesh-based Square Pharmaceuticals says the fees are burdensome for first-time filers, given long approval times, but the firm’s citizen petition strategy may further delay approval of its ANDA.
FDA says it likely will oppose the provision because it would create more administrative complexity and increase fees paid by individual firms, but many provider and professional associations think waivers could help prevent and alleviate drug shortages.
When Ralph Neas joins the Generic Pharmaceutical Association as CEO on Sept. 12 he will face many of the same challenges he’s had as CEO of the National Coalition on Health Care: energizing reform-minded partners to advocate for legislative and policy changes.