Regulatory Focus

At some advisory committee meetings, more than half of patient and consumer representatives who attended had connections to organizations with these active ties to industry.

The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practices (CGMP) requirements, and to a research laboratory for failing to comply with good laboratory practices (GLP). The specific issues include concerns about ensuring that final products are sterile and meet specifications, and, in the case of the research laboratory, that the final report adequately details the experience of its animal subjects.

A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to facilitate the development and marketing of treatments for rare diseases, according to a 14 October announcement from the agency.

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Congress should enact a specific regulatory framework for artificial intelligence (AI) models developed and used in academic medical centers, Scott Gottlieb argued in an opinion piece published in JAMA Health Forum. Such systems should not be regulated as commercial medical devices or left unregulated, according to Gottlieb, a former Commissioner of Food and Drugs, now at the American Enterprise Institute. Three experts who spoke with Focus said they support the plan.

In January, the European Medicines Agency (EMA) will make permanent a pilot project that helps sponsors prepare clinical trial applications.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a multi-year strategy aimed at ensuring continued patient-centered regulation in the era of emerging artificial intelligence (AI) and personalized medicine. The plan outlines commitments and steps the agency should take through 2030 to keep pace with rapid technological and scientific developments and bring safe and effective treatments to patients more quickly.

Stakeholders are urging the US Food and Drug Administration (FDA) to be flexible in how it regulates psychedelic drugs that may help treat conditions such as major depressive disorder (MDD) and post-traumatic stress disorder (PTSD). The agency should be careful not to create unnecessary barriers to patient access, promote proper training and credentialing, and allow flexibility in updating labeling as additional knowledge becomes available, according to individuals and groups that commented via a public docket.