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Pharmaceuticals / Regulatory Affairs

FDA Clears Up Requirements for Notice Provisions in ANDA, 505(b)(2) Application Review

Oct. 12, 2016

The FDA has issued a final rule that clarifies and standardizes the regulatory review process for 505(b)(2) applications and ANDAs.

To reduce unnecessary litigation that often delays the approval of products otherwise ready for the market, the rule codifies several longstanding requirements and provisions that involve patent holders, ANDA sponsors and 505(b)(2) applicants, the FDA said in the preamble to the rule.

The rule, for instance, stipulates that drugmakers must submit precise descriptions of approved indications for which the product is protected by a patent.

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