Tower Mains Weekly Newsletter
Company Updates
Meet our Senior Associate, Anna Lothian
After graduating with a first-class honours degree in Biomedical Sciences from the University of Dundee, Anna began her career in the medical device field, starting as a lab technician and working towards a technical manager role in Research & Development before joining Tower Mains as Senior Associate in 2023. Click here to find out what initially attracted Anna to QA, her career highlights, and what makes her tick outside of work.
Regulatory Updates
MHRA publishes overview of timelines for placing CE-marked IVDs on the UK market
On 16th June, the Medicines and Healthcare products Regulatory Agency (MHRA) published an overview of timelines for placing CE-marked IVDs on the UK market in its information on the implementation of medical devices future regime.
MHRA launches new guidance on the use of life-saving adrenaline auto-injectors
On 19th June, coinciding with the start of World Allergy Week, the MHRA launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis which includes an easy step-by-step guide on what to do in an emergency and provides updated advice on body positioning.
Further MHRA guidance updates
- Regulating medical devices in the UK. On 16th June, the MHRA published guidance on what is needed to place a medical device on the UK, Northern Ireland and EU markets. Click to view source
- Borderline products: how to tell if your product is a medicine. On 20th June, regulation 165 notices from October 2019 to May 2023 were added to MHRA guidance on how it makes decisions on what is a medicinal product (borderline products). Click to view source
- Dialysis guidance. On 21st June, MHRA dialysis guidance was updated following engagement with Healthcare Safety Investigation Branch (HSIB) relating to their investigation: ‘Safety risks associated with central venous catheters (CVCs) used for haemodialysis treatment’. Click to view source
FDA guidance updates
- Content of premarket submissions for device software functions. On 16th June, the US Food and Drug Administration (FDA) published final guidance to provide information regarding the recommended documentation for premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions, which are software functions that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Click to view source
- Drug-drug interaction assessment for therapeutic proteins guidance for industry. On 21st June, final guidance was published to help sponsors of investigational new drug (IND) applications and applicants of biologic license applications (BLAs) determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing recommendations for a systematic, risk-based approach. Click to view source
Industry Updates
EMA issues highlights from the latest CVMP meeting
On 16th June, the European Medicines Agency (EMA) issued meeting highlights from its Committee for Veterinary Medicinal Products (CVMP) held on the 13th-15th of June 2023. Topics include novel therapies & technologies, pharmacovigilance and opinions on veterinary medicinal products Under Regulation (EU) 2019/6.
genedrive awarded test kit grant
On 16th June, genedrive plc, a molecular diagnostics company, announced its participation in the Development and Validation of Technology for Time Critical Genomic Testing (DEVOTE), a multi-partner grant award from the UK government Innovation Accelerator programme and Innovate UK. Funding is expected to be made available to further the validation and implementation of the new Genedrive® CYP2C19 ID Kit pharmacogenetic test in a time-critical clinical setting.
Updated COVID-19 vaccine information for Autumn/Winter 2023-2024 published on FDA website
On 16th June, the FDA advised manufacturers seeking to update their COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition. This recommendation incorporates advisory committee input and is based on the totality of the available evidence to select the vaccine composition that the FDA anticipates will best protect public health.
New lay commissioner appointed to the Commission on Human Medicines
On 19th June, the MHRA announced the appointment of Mr David Crundwell as a lay commissioner of the Commission on Human Medicines (CHM) for four years, per the Cabinet Office Code of Governance for Public Appointments. The CHM provides independent expert advice to ministers on the safety, quality and efficacy of medicines, and on adverse reactions including those reported under the Yellow Card Scheme.
FluoGuide announces positive results from phase IIa trial of FG001 in head & neck cancer
On 20th June, FluoGuide A/S, a Danish biotech company that pioneers precision cancer surgery, announced positive interim results from the phase IIa trial of its lead product FG001 in head & neck cancer. The treatment demonstrated the ability to illuminate tumours in all of the participating individuals, and data showed that all 12 patients within the first two cohorts – who were undergoing surgery for head and neck squamous cell carcinomas (HNSCC) – had their tumours identified with FG001.
Pilot launched in US to help reduce risks associated with laboratory-developed tests to identify cancer biomarkers
On 20th June, the FDA announced a voluntary pilot program for certain oncology drug products used with certain in vitro diagnostic tests to help identify appropriate cancer treatments for patients. Through the program, the FDA will request, from drug manufacturers, performance information for the tests used to enrol patients into the clinical trials that support drug approval, and based on an assessment of that information, the FDA will publish the minimum performance characteristics recommended for similar tests that may be used to select patients for treatment with the approved drug. This aims to help facilitate better and more consistent performance of these tests, resulting in better drug selection and improved care for patients with cancer.
FDA approves new class of medicines to treat pediatric type 2 diabetes
On 20th June, the FDA approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes.
Assembly of ICH information released
On 20th June, the International Council for Harmonisation (ICH) released information from its in-person Assembly held on the 12th & 13th of June 2023, in Vancouver, Canada. This includes the three new topics for harmonisation, progress on ICH Guideline Development and Important Revisions, and updates on MedDRA.
Issue Number: WN00117
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