The FDA has issued a draft guidance: "Safety Considerations for Product Design to Minimize Medication Errors" that provides drug sponsors with a set of principles for developing drug products using a systems approach to minimize medication errors relating to product design.

The FDA said that improvements in drug product and container closure design can enhance patient safety by reducing medication errors.

The guidance is the first in a series of three planned guidances to minimize risks contributing to medication errors. The second will focus on minimizing risks with the design of drug product container labels, carton labeling and packaging configurations, and the third guidance will focus on minimizing risks with drug product nomenclature. Sponsors will have 60 days to provide their feedback.

More guidance news from the FDA involved draft and revised draft product-specific bioequivalence (BE) recommendations that provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDA).

As part of a commitment to accelerate drug approval times, the FDA released its draft guidance on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in NDAs and biologics license applications.

The detailed document focuses on enrichment designed to improve the ability of a study to detect a drug's effectiveness; however, it noted that similar strategies can be used in safety assessments.

In another matter, the agency is extending the expiration date to Dec. 31, 2014, of its compliance policy guide (CPG) on the radiofrequency identification (RFID) feasibility study for drugs. The FDA identified RFID as a promising technology, and the goal of the CPG, the FDA said, is to facilitate performance of RFID studies and to allow industry to gain experience with the use of RFID technology and its effect on the long-term safety and integrity of the U.S. drug supply. A California statute takes effect in 2015, which requires a full electronic track-and-trace capability designed to determine the entire distribution history and location, at any time, of every unit in the supply chain. (See BioWorld Today, Oct. 26, 2012.)

PCORI Connects Researchers, Patients

The Washington-based Patient-Centered Outcomes Research Institute (PCORI) has introduced a competition to create a system for connecting health care researchers and patient partners to advance patient-centered comparative effectiveness research. The PCORI Challenge will award cash prizes to the winning developers in two categories: conceptual model ($10,000) and prototype ($40,000). Deadline for entries is April 15, 2013.