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Health Agency Releases Regulatory Agenda Update, Includes FDA Regulations in Development

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By Alexander Gaffney

The US Department of Health and Human Services released their semiannual regulatory agenda on 13 February, which is an “inventory of rulemaking actions under development throughout DHHS with a view to offering summarized information about forthcoming regulatory actions for public review.”

The regulatory agenda includes numerous US Food and Drug Administration (FDA) activities in the pre-rule, proposed rule, final rule and long-term stages of development.

Notably, FDA is currently formulating rules about over-the-counter (OTC) sunscreen products. FDA is similarly conducting Section 610 reviews of the Prescription Drug Marketing Act of 1987, Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents, and General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification.

FDA also has a number of regulations in the “proposed rule stage,” including the Unique Device Identification rule. Politico reported last week that the Office of Management and Budget is mysteriously holding up this regulation, leading to frustration at FDA and in Congress.

The unique identification system, mandated in 2007 under the Food and Drug Administration Amendments Act (FDAAA), is intended to standardize how medical devices are tracked. Congress envisioned a simple system similar to how groceries are scanned at a checkout counter. The proposed regulation has been complete since 2011, but held up at OMB for “reasons that are unclear.”




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