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Pharmaceuticals / Regulatory Affairs

Semiannual Agenda Flags Upcoming FDA Regulatory Actions

June 12, 2018
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HHS released its latest regulatory agenda for in-development rulemakings including 20 specific to the FDA.

The agency anticipates issuing a final rule in December 2018 on postmarketing safety reporting for human drugs and biological products including blood and blood products. This rule will align FDA requirements with International Council on Harmonization guidelines on Technical Requirements for Registration of Pharmaceuticals for Human Use and update reporting requirements in light of current pharmacovigilance practice.

The agency also plans to issue a notice of proposed rulemaking by February 2019 to require a new form of patient labeling — Patient Medication Information — for human prescription drug products and certain blood products dispensed or administered on an out-patient basis.

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