Tower Mains Weekly Newsletter
Company Updates
We Are Hiring: Principal Associate, Clinical QA
Tower Mains is looking for an experienced individual to join our team in support of clinical audit and consultancy services supporting GCP training, audit, and client QAU and QMS development. The role is flexible and can be adapted to the right person for hours and travel. For more information, click here.
Visit us at the Diagnostics North East Conference 2024
Delighted to announce that we will be exhibiting at the Diagnostics North East Conference in Newcastle this Friday, 19th April. Looking forward to seeing new and familiar faces, and hearing from industry experts. For more information on the event, click here.
Regulatory Updates
MHRA guidance updates
- RegulatoryConnect. On 15th April, a link to the RegulatoryConnect webinar was added. RegulatoryConnect is a service that provides the capability to track applications and view live authorisation details. Click to view source
- 150-day assessment for national applications for medicines. On 16th April, the email address used to request pre-submission advice was updated to presubmission@mhra.gov.uk. Click to view source
FDA data standards catalog
On 16th April, the US Food & Drug Administration (FDA) published its updated data standards catalog.
Global regulators publish report following workshop on COVID-19 vaccine strain updates
On 17th April, global regulators published a report presenting the outcomes of a workshop on COVID-19 vaccine strain updates that was organised by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organisation (WHO). The report provides an overview of key regulatory considerations related to updated COVID-19 vaccine composition and highlights data requirements for authorised vaccines to support the approval of strain changes.
Industry Updates
NHS AI Lab: Building the AI and Digital Regulations Service
On 8th April, the NHS issued an update on how the National Institute for Health and Care Excellence (NICE), the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Care Quality Commission (CQC) collaborated with the NHS Artificial Intelligence (AI) Lab to set up the AI and Digital Regulations Service to guide developers and adopters of AI and digital technologies.
FDA takes several actions to understand surgical mesh mini-slings to treat female SUI
On 11th April, the FDA announced several actions have been taken to better understand the safety and effectiveness of surgical mesh mini-slings to treat female stress urinary incontinence (SUI) including evaluating the results of long-term follow-up studies and completing an in-depth literature review to evaluate the performance of the mini-slings compared to the traditional mid-urethral slings. The results continue to support the FDA’s conclusion that mini-slings have comparable clinical performance to traditional mid-urethral slings through at least 36 months for treating female SUI. The FDA’s recommendations have not changed.
Francis Crick researchers uncover pathways linking intestinal inflammation and colitis
On 12th April, the Francis Crick Institute announced its researchers have untangled a complex pathway that could help explain how interactions between microorganisms and the body’s immune defences lead to gut inflammation and colitis.
Bio-Rad and Oncocyte collaborate to commercialise transplant monitoring with Droplet Digital PCR
On 12th April, Bio-Rad Laboratories, Inc., a global leader in life science research and clinical diagnostics products, announced a collaboration agreement with Oncocyte Corporation, a precision diagnostics company, to develop and commercialise transplant monitoring products using Bio-Rad’s Droplet Digital™ PCR (ddPCR™) instruments and reagents.
WHO and the Netherlands strengthen their partnership
On 12th April, information was published on the outcome of a meeting between the World Health Organisation (WHO) and the Netherlands. The meeting, held on the 10th of April 2024, discussed joint priorities and alignment between the Dutch Global Health Strategy and WHO’s key strategic goals, marking a new milestone in their longstanding partnership. A key outcome was the recognition of the alignment between the Dutch Global Health Strategy and the WHO’s forthcoming 14th General Programme of Work, paving the way for synergies in areas such as health system strengthening, pandemic preparedness, climate change and health, anti-microbial resistance (AMR) and mental health support.
FDA establishes CDER Center for Clinical Trial Innovation (C3TI)
On 15th April, the FDA’s Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally. C3TI will be a central hub that supports innovative approaches to clinical trials that are designed to improve the efficiency of drug development and will facilitate the sharing of lessons learned across CDER’s existing clinical trial innovation initiatives and will communicate and collaborate with external parties.
Specific nasal cells protect against COVID-19 in paediatric patients
On 15th April, it was announced that researchers from the University College London (UCL) and the Wellcome Sanger Institute have revealed how specific nasal cells differ in children and elderly people when protecting against COVID-19. Published in Nature Microbiology, the study used cells donated by healthy participants from Great Ormond Street Hospital, University College London Hospital, and the Royal Free Hospital.
CDRH unveils dataset to improve chemical characterisation methods for biocompatibility of medical devices
On 16th April, the FDA’s Center for Devices and Radiological Health (CDRH) is unveiling a new public dataset designed to help assist chemistry labs in ensuring the robustness of chemical characterisation methods used to assess the biocompatibility of medical devices.
ELRIG UK and SRG collaborate to advance life sciences professionals in drug discovery
On 16th April, the European Laboratory Research & Innovation Group (ELRIG) UK, a volunteer-led organisation for the drug discovery community, entered a partnership with SRG, leaders in life science recruitment, to support the advancement of science professionals in their careers. The partnership offers the ELRIG community access to career opportunities and provides organisations of all sizes with SRG’s specialist talent solutions to help grow the life science sector.
Issue Number: WN00158
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