Ferdous Al-Faruque

The US Food and Drug Administration (FDA) last week finalized its guidance on postapproval manufacturing changes for biosimilars to better align with international guidelines and to better address manufacturing changes for interchangeable products, which were not addressed by earlier guidance.

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.

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.

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.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we're reading from around the web. This week, there are reports that some staff are concerned that a new HHS performance assessment could be a prelude to more layoffs, former FDA chiefs criticized last year's mass firings, and more.

BOSTON – Despite some early jitters, the medtech industry is coming around to the Quality Management System Regulation (QMSR), according to a top industry executive who spoke at The MedTech Conference on Monday.

Boston – Regulators from the US and UK discussed ongoing efforts to develop regulatory frameworks that are better suited to generative artificial intelligence (genAI) products at The MedTech Conference on Tuesday.

BOSTON – Top US Food and Drug Administration (FDA) medical device officials said they are focused on restaffing after last year's reduction-in-force (RIF) and are optimistic about the Medical Device User Fee Amendments (MDUFA VI) agreement during a town hall panel at The MedTech Conference.

BOSTON – There needs to be a cultural shift to foster trust between regulators and the medtech industry when developing real-world evidence (RWE) to support the marketing of medical devices, according to experts who spoke at The MedTech Conference on Monday. They also noted that developing standards is key to expanding the use of RWE.

BOSTON – An expert and officials from the US Food and Drug Administration (FDA) offered tips for de novo classification requests and reviewed some of the changes related to de novos being proposed under the Medical Device User Fee Amendments (MDUFA VI) program at The MedTech Conference last week.