FDA Commissioner Scott Gottlieb, MD, on Wednesday outlined new steps the agency will take to spur more generic drug competition.
Here are three things to know.
1. The agency's three-part Drug Competition Action Plan to stimulate generic drug approvals involves preventing companies from using unfair tactics to delay generic competition, removing scientific and regulatory obstacles from the generic approval process, and streamlining the internal review process to achieve generic approvals faster.
2. The FDA released two documents Wednesday to improve the submission and review of generic drug applications. The first, a draft guidance called "Good ANDA Submission Practices," lists the most common deficiencies the agency encounters in applications that can lead to a delayed approval. The FDA hopes drug companies can use this resource to submit stronger applications the first time and limit multiple cycles of regulatory review.
3. The agency also released a companion document to the draft guidance, which summarizes drug application assessment processes for FDA staff. "The document formalizes a more streamlined generic review process, including the introduction of new templates that will make each cycle of the review process more efficient and complete," Dr. Gottlieb said Wednesday.
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