Tower Mains Weekly Newsletter
Company Updates
We Are Hiring: Principal Associate, Clinical QA
We are 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 SQA 40th Annual Meeting
This week, Tower Mains’ Head of Quality Assurance Shona Ross and Senior Associate Nicole Ainsworth will be heading to Colorado for the upcoming Society of Quality Assurance 40th Annual Meeting. Are you also attending? Come by booth 205 and say hello!
Whether you’re curious about what Tower Mains has to offer or simply want to connect, drop us a line at info@towermains.com or reach out to Shona or Nicole directly. We’d love to chat!
Regulatory Updates
MHRA updates
- Assistive technology: definitions, examples, and safe use. On 3rd April, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance to provide clearer information to help understand the definition of assistive technology and the difference between medical devices and aids to daily living. Click to view source
- ICH Guidelines. On 4th April, a directory of current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines which have been implemented by the MHRA was published. Click to view source
FDA guidance updates
- FDA regional implementation guide for E2B(R3) electronic transmission of individual case safety reports for drug and biological products. On 1st April, final guidance was issued by the the US Food & Drug Administration (FDA) to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Click to view source
- Providing regulatory submissions in electronic format: IND safety reports guidance for industry. On 1st April, final guidance was published to describe the electronic format sponsors will be required to use when they electronically submit investigational new drug (IND) safety reports to CDER and CBER for serious and unexpected suspected adverse reactions, as required under 21 CFR 312.32(c)(1)(I). FDA is establishing the electronic format requirements described in this guidance under section 745A(a) of the FD&C Act (21 U.S.C. 379k-1(a)). Click to view source
- Electronic submission of expedited safety reports from IND-Exempt BA/BE studies guidance for industry. On 1st April, final guidance was published to provide instructions for the electronic submission of expedited ICSRs from IND-exempt bioavailability (BA)/bioequivalence (BE) studies conducted to support abbreviated new drug applications (ANDAs) to FDA Adverse Event Reporting System (FAERS). Click to view source
- Data integrity for in vivo Bioavailability and Bioequivalence studies. On 3rd April, the FDA issued draft guidance providing recommendations to applicants and testing site management on achieving and maintaining data integrity for the clinical and bioanalytical portions of BA and BE studies submitted in support of INDs, new drug applications (NDAs), and ANDAs, and the bioanalytical portion of clinical pharmacologic studies supporting CDER-regulated biologic license applications (BLAs) as well as amendments and supplements to these applications. Click to view source
Industry Updates
WHO launches global network for coronaviruses
On 27th March, the World Health Organisation (WHO) announced the launch of a new network for coronaviruses, CoViNet, to facilitate and coordinate global expertise and capacities for early and accurate detection, monitoring, and assessment of SARS-CoV-2, MERS-CoV and novel coronaviruses of public health importance. The network currently includes 36 laboratories from 21 countries in all six WHO regions.
State-of-the-art liquid biopsy to benefit lung cancer patients in expanded NHS study
On 27th March, it was announced that a new ‘liquid biopsy test’ called the Marsden360 – developed by The Royal Marsden and Guardant Health – has already enabled over 2000 patients with suspected advanced lung cancer to have a ctDNA blood test before or while diagnostic biopsies are taken. NHS England is now rolling out the test to an additional 10,000 patients over the next year, in a bid to speed up and personalise treatment.
CERENOVUS launches minimally invasive stroke care innovation with liquid embolic system procedural set
On 28th March, CERENOVUS Inc., part of Johnson & Johnson MedTech, announced the launch of the TRUFILL™ n-BCA Liquid Embolic System Procedural Set. Designed to address the challenges in the treatment of haemorrhagic stroke by simplifying procedure preparation, it is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via super-selective catheter delivery when pre-surgical devascularisation is desired.
New targeting tool detects signs of motor neuron disease before symptoms begin
On 28th March, it was revealed that scientists from the University of Aberdeen and University of Edinburgh, alongside international partners, have identified a new way to detect signs of motor neuron disease (MND) in brain tissue that can pick up indicators of MND earlier and with more sensitivity than currently used tests. The research, led by Dr Jenna Gregory from the University of Aberdeen, predicts the newly developed aptamer could trigger a step-change in MND research, supplementing or replacing some traditional antibody approaches for detection.
New label statement assures safety and effectiveness of animal drugs
On 1st April, the FDA issued an update and a separate letter to veterinarians informing them that the statement “Approved by FDA” is mandatory on most labelling components for approved animal drugs. As required by amendments in the Animal Drug User Fee Act and Animal Generic Drug User Fee Act of 2018, the labelling statement is intended to help veterinarians, food animal producers, pet owners, and others identify approved animal drugs and distinguish them from unapproved ones.
FDA approves injectable antibiotic for three indications
On 4th April, Basilea Pharmaceutica Ltd, a commercial-stage biopharmaceutical company focused on meeting the needs of patients with severe bacterial and fungal infections, announced that the FDA has approved ZEVTERA® for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and paediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).
Issue Number: WN00156
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