New Proposed cGMP Rules Planned for Second Half of 2013

The federal government has signaled a new push to overhaul pharmaceutical current good manufacturing practices (cGMPs) to emphasize risk management.

In an updated regulatory agenda for 2013, posted last week, HHS details 15 new FDA-related proposed and final rules. The revisions to cGMP regulations aim to improve existing requirements and improve detection of and response to safety and quality issues.

Some changes to cGMPs are already afoot. The agency earlier this year revealed plans to publish guidance on introducing a quality system approach to drug cGMPs.

Other FDA-related agenda items on the HHS agenda include:

• Reviewing the Prescription Drug Marketing Act by November to determine whether regulations should be changed or rescinded to minimize adverse impacts on small businesses;
• Developing a proposed rule to change certain procedures for ANDAs relating to patent certifications, including the type of bioavailability and bioequivalence data needed to support such applications; and
• Establishing a list of “qualifying pathogens” that could pose a serious public health threat. This is required under the Generating Antibiotic Incentives Now section of the FDA Safety and Innovation Act.

True or false: Everest is the tallest mountain on Earth?

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(By the way, the answer is false: there’s an underwater mountain off the coast of Hawaii that stands more than 29,000 feet off the sea floor; Everest is the highest mountain in the world but not the tallest).