In this week’s news, FDA teams focus on machine learning guidelines for medical devices sector and more…

US FDA, Health Canada and the MHRA team up on machine learning for devices guide

The US FDA is working with Health Canada and the UK’s MHRA to develop a set of best practices for drug industry use of machine learning in medical devices.

The collaboration – details of which were disclosed this week – has develop 10 “guiding principles” that cover everything from use justification and clinical development through to device security requirements.

The organisation wrote, “We believe these guiding principles will help advance the development of machine learning technologies for medical devices.”

ISPC weighs in on FDA’s approach to ICH Q12

The International Society for Pharmaceutical Engineering wants the US FDA to call for revisions to the International Council for Harmonization’s (ICH) Q12 guideline on post-approval changes to manufacturing.

In addition to asking for several technical changes that it said would reduce the risk of regulatory divergence, the industry group called on the FDA to eliminate the requirement that applicants submit annual reports for all modified analytical procedures.

The ISPE said, “There should be no requirement to submit them in an annual report. The expectation to submit analytical procedures in Annual Reports essentially makes all analytical procedure parameters ECs, which is not the intended outcome of ICH Q12.”

Also in the news

Inside Health Policy covered the passage of a US bill about continuous manufacturing and the role it will play in securing the supply of medicines in the country.

The Pinksheet looked at the trials and tribulations of marketing cell and gene therapies.

The US GAO says the US FDA did not to inspect any facilities involved in making COVID-19 vaccines granted emergency use authorisation. See more at Endpoints.

Reuters reported that Merck & Co has agreed with the UN Medicines Patent Pool (MPP) to let more companies to make generic versions of its experimental oral antiviral COVID-19 treatment.

The European Commission has identified 10 promising COVID-19 treatments. The list includes monoclonal antibodies, oral antivirals and immunomodulators.

CDMO trends

Some developments of note in the contracting sector:

Recro Pharma has been awarded a new development and manufacturing contract by the US National Center for Advancing Translational Sciences (NCATS). The project is focused on NES-100, a novel nasal spray analgesic.

PharmaTher Holdings has hired Alcami for the clinical and commercial manufacturing of its proprietary ketamine products.

Exacis Biotherapeutics has contracted the Toronto-based Centre for Commercialization of Regenerative Medicine (CCRM) for the development of its iPSC-derived mRNA-engineered NK cell products to treat cancer.

Fujifilm Diosynth Biotechnologies has started building in Holly Springs, North Carolina. The site is expected to be operational by spring 2025.

Evergreen Theragnostics has opened a manufacturing facility in Springfield, New Jersey.

Phlow has been approved for inclusion in the Biomedical Advanced Research and Development Authority (BARDA) contract development and manufacturing organization (CDMO) network.