Tower Mains Weekly Newsletter
Our brand-new course ‘Conducting Laboratory Investigations’ and our newly updated ‘Fundamentals of Good Manufacturing Practice’ course are now on the website and available to book.
We currently have spaces available on the following training courses…
- 12th June 2023: Conducting Laboratory Investigations
- 13th-14th June 2023: Research Audit and Inspection
- 15th August 2023: Fundamentals of GCP
- 16th-17th August 2023: Research Audit and Inspection
- 18th August 2023: Conducting Laboratory Investigations
- 17th October 2023: Fundamentals of GMP
For further information on each course, visit our website, or if you are interested in discussing your specific training requirements or if you wish to book for your group or organisation, please don’t hesitate to contact email@example.com.
Reporting adverse incidents involving Software as a Medical Device under the vigilance system
On 15th May, the Medicines and Healthcare products Regulatory Agency (MHRA) published guidance for manufacturers of Software as a Medical Device, detailing events that may cause indirect harm and are therefore reportable. It should be read in combination with the guidelines on a medical devices vigilance system MEDDEV 2.12/1 rev 8 which sets out the general adverse incident reporting obligations on all manufacturers of medical devices including software as a medical device.
Further MHRA guidance updates
- Notifying the MHRA about a clinical investigation for a medical device. On 11th May, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on notifying the agency of intentions to carry out a clinical investigation for medical devices. Click to view source
- The qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF): On 11th May, MHRA updated its guidance to reflect that it is no longer a requirement to submit a Type IA(IN) variation and an accompanying eCTD sequence to make these changes. This has been simplified and only an update notification is required, there is no requirement to submit an eCTD sequence. Click to view source
- Medical devices: software applications. On 16th May, the ‘Medical device stand-alone software including apps’ file was updated to include information on the implementation of new regulations, updates to various links including MORE and new software vigilance guidance. Click to view source
EMA publishes annual report 2022
On 15th May, the European Medicines Agency (EMA) published its 2022 annual , outlining the most important highlights regarding evaluating and monitoring human and veterinary medicines and selecting key figures. It also contains an interactive timeline of important milestones in 2022, with advanced functionalities that allow readers to explore each topic in more depth by accessing additional documents, audio-visual materials and infographics. To read more, click here.
Guidance for industry to prevent and mitigate medicine shortages
On 17th May, the European Medicines Agency published guidance on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact. It describes the various stakeholders involved in the medicine supply chain and their responsibilities in the prevention and management of medicine shortages and provides ten recommendations to minimise the occurrence of medicine shortages and their impact.
FDA guidance updates
- Reporting and mitigating animal drug shortages: On 12th May, the US Food and Drug Administration (FDA) published final guidance to assist sponsors in providing the FDA with timely, informative notifications about changes in the production of animal drugs that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of these products. Click to view source
- Pediatric drug development: Scientific considerations. On 17th May, draft guidance was published aimed at assisting industry in developing data and obtaining information needed to support the approval of drug products in pediatric populations. This guidance addresses selected clinical, scientific, and ethical issues regarding the development of drugs for pediatric use when such drugs are subject to the Pediatric Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children Act (BPCA). Click to view source
First drug to treat agitation symptoms associated with dementia due to Alzheimer’s disease approved in US
On 11th May, the FDA announced the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease, the first FDA-approved treatment option for this indication. The agency granted this application Fast Track designation, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Innovative drug approved to treat moderate to severe hot flashes caused by menopause
On 12th May, the FDA approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause and works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.
MHRA performance data for assessment of clinical trials and established medicines
On 15th May, the MHRA published performance metrics for clinical trials and established medicines assessment for the period January to April 2023.
Globus Medical announces FDA approval for its non-fusion scoliosis correction system
On 15th May, Globus Medical, a leading musculoskeletal solutions company, announced its REFLECT™ Scoliosis Correction System has been approved by the FDA. REFLECT™ is designed to correct progressive scoliosis in young patients while preserving motion, maintaining stability, and allowing for future modulated growth. The system is the second-of-a-kind anterior vertebral body tether device approved under the Humanitarian Device Exemption (HDE) Program.
Closed Loop Medicine and Pharmanovia enter precision medicine partnership
On 17th May, Closed Loop Medicine Ltd, a TechBio company, and Pharmanovia, a global pharmaceutical company that commercialises novel medicines and revitalizes, extends and expands the lifecycle of established medicines, announced that they have entered a co-development partnership. The partnership will initially focus on the development and launch of a drug and software combination version of a first-line anti-hypertensive in the UK before phased global roll-out and additional therapies are added.
Issue Number: WN00112
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