Weekly News

Tower Mains Weekly Newsletter Company Updates After a successful 2022, we are looking forward to further expanding our expert team, [...]

Tower Mains Weekly Newsletter Regulatory Updates FDA issues guidance for sponsors in the clinical development of drugs for the treatment [...]

Tower Mains Weekly Newsletter Regulatory Updates FDA signs MRA between US and Switzerland relating to GMP On 12th January, the [...]

Tower Mains Weekly Newsletter Regulatory Updates MHRA extends consultation on how it communicates with healthcare professionals to improve medicines and [...]

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance update: Exceptional use of non-UKCA marked medical devices On 30th December, the [...]

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates On 14th December, the Medicines and Healthcare products Regulatory Agency (MHRA) [...]

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates On 9th December, the Medicines and Healthcare products Regulatory Agency (MHRA) [...]

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates  On 5th December, the Medicines and Healthcare products Regulatory Agency (MHRA) [...]

Tower Mains Weekly Newsletter Regulatory Updates MHRA updates data on clinical trials for medicines On 29th November, the Medicines and [...]

Tower Mains Weekly Newsletter Company Updates Scotsman Life Sciences Conference 2022 Tower Mains is delighted to be exhibiting at the [...]

Tower Mains Weekly Newsletter Company Updates RQA RE: UNITED International Conference We were delighted to attend and participate in the [...]

Tower Mains Weekly Newsletter Company Updates RQA RE: UNITED International Conference We are delighted to be attending the Research Quality [...]

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates On 28th October, guidance on how the Medicines and Healthcare products [...]

Tower Mains Weekly Newsletter Industry Updates EMA recommends approval of second adapted Spikevax vaccine On 19th October, the European Medicines [...]

Tower Mains Weekly Newsletter Regulatory Updates MHRA updates guidance on its Software and AI as a Medical Device Change Programme [...]

Tower Mains Weekly Newsletter Regulatory Updates ICH E19 Guideline reaches Step 4 of the ICH Process On 4th October, the [...]

Tower Mains Weekly Newsletter Regulatory Updates MHRA appoints first UK Approved Body to certify medical devices since Brexit On 29th [...]

Tower Mains Weekly Newsletter Regulatory Updates FDA publishes draft guidance aiming to protect children who participate in clinical trials  On [...]

Tower Mains Weekly Newsletter Regulatory Updates EMA and HMA confirm biosimilar medicines can be interchanged On 19th September, the EMA [...]

Tower Mains Weekly Newsletter Industry Updates EMA approves adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 On [...]

Tower Mains Weekly Newsletter Industry Updates First adapted COVID-19 booster vaccines recommended for approval in the EU  On 1st September, [...]

Tower Mains Weekly Newsletter Company Updates Check out our latest ‘Meet the Team’ blog post on our Head of Clinical [...]

Tower Mains Weekly Newsletter Company News Risk Management in your Quality Management System (QMS) – is it effective? In their [...]

Tower Mains Weekly Newsletter Company Updates We have been published in the August issue of QUASAR, the Research Quality Association [...]

Tower Mains Weekly Newsletter Company Updates We have exciting news! Tower Mains is delighted to announce the following promotions:   Our [...]

Tower Mains Weekly Newsletter Regulatory Updates International Council on Harmonisation (ICH) M10 Guideline Issued On 27th July, final ICH M10 [...]

Tower Mains Weekly Newsletter Industry Updates EMA to hold second Veterinary Big Data Stakeholder Forum Following the success of the [...]

Tower Mains Weekly Newsletter Breaking News Organisation for Economic Co-operation and Development (OECD) document updates On 18th July, the OECD [...]

Tower Mains Weekly Newsletter Industry Updates FDA authorises pharmacists to prescribe Paxlovid with certain limitations On 6th July, the US [...]

Tower Mains Weekly Newsletter Industry Updates FDA recommends inclusion of Omicron BA.4/5 component for COVID-19 vaccine booster doses Following a [...]

Tower Mains Weekly Newsletter Industry Updates FDA unveils strategy for scientific advancement and promoting innovation for rare neurodegenerative diseases On [...]

Tower Mains Weekly Newsletter Industry Updates MHRA to play a greater role in setting global standards for medicines and medical [...]

Tower Mains Weekly Newsletter Industry Updates MHRA Spikevax vaccine update On 10th June, the Medicines and Healthcare products Regulatory Agency [...]

Tower Mains Weekly Newsletter Industry Updates FDA opens FY2023 grant funding application period for animal drugs for minor uses and [...]

Tower Mains Weekly Newsletter Company Updates Thank you to those who attended our Lunch and Learn on Wednesday, 1st June, [...]

Tower Mains Weekly Newsletter Industry Updates FDA urges drug manufacturers to develop and implement risk management plans On 19th May, [...]

Tower Mains Weekly Newsletter Company Updates WHO and MPP announce agreement with NIH for COVID-19 health technologies On 12th May, [...]

Tower Mains Weekly Newsletter Company Updates Tower Mains is delighted to welcome Olga Pavlovska as Senior Associate. Olga will be providing clinical [...]

Tower Mains Weekly Newsletter Industry Updates FDA approves first device indicated for the preservation of donation-after-circulatory-death hearts On 27th April, [...]

Tower Mains Weekly Newsletter Industry Updates FDA publishes guidance on the development of drug products including those that contain nanomaterials [...]

Tower Mains Weekly Newsletter Industry Updates FDA authorises first COVID-19 diagnostic test using breath samples On 14th April, the US [...]

Tower Mains Weekly Newsletter Industry Updates ECDC and EMA conclude it’s too early to consider using a fourth dose of [...]

Tower Mains Weekly Newsletter Industry Updates MHRA phase I accreditation scheme guidance updated  On 30th March, the Medicines and Healthcare [...]

Tower Mains Weekly Newsletter Industry Updates EMA recommends authorisation of Evusheld for treatment of COVID-19 On 24th March, the European [...]

Tower Mains Weekly Newsletter Industry Updates MHRA publishes video recording of the Medicines Supply for Northern Ireland webinar On 16th [...]

Tower Mains Weekly Newsletter Industry Updates The MHRA and other organisations across the UK unite to improve public involvement in [...]

Tower Mains Weekly Newsletter Industry Updates EMA’s PRIME scheme enables earlier availability of life-changing medicines On 3rd March, the European [...]

Tower Mains Weekly Newsletter Industry Updates MHRA updates guidance on clinical trials applications submitted for COVID-19 On 23rd February, the [...]

Tower Mains Weekly Newsletter Regulatory Updates Eudralex Volume 4 Annex 21 Importation of medicinal products published 16 February 2022 The [...]

Tower Mains Weekly Newsletter Industry Updates EMA issues meeting highlights from February PRAC meeting On 11th February, the European Medicines [...]

Tower Mains Weekly Newsletter Industry Updates MHRA approves Novavax COVID-19 vaccine Nuvaxovid On 3rd February, the Medicines and Healthcare products [...]

Tower Mains Weekly Newsletter Company Update Tower Mains is hiring! We are on the lookout for an Associate to further [...]

Tower Mains Weekly Newsletter Industry Updates FDA releases CDRH Health of Women Strategic Plan to better inform medical device research [...]

Tower Mains Weekly Newsletter Company Updates We have been published in this month’s issue of QUASAR, the Research Quality Association (RQA)'s [...]

Tower Mains welcomes Marina to the team Tower Mains is delighted to welcome back Marina Freiberga. Marina joined TMQA in [...]

Tower Mains Weekly Newsletter Company Updates Tower Mains is pleased to announce the following senior appointments: Rhona McAteer has been promoted [...]

Tower Mains Weekly Newsletter Industry Updates EMA launches the Regulatory Science Research Needs initiative ​​​​On 15th December, the European Medicines [...]

Tower Mains Weekly Newsletter Industry Updates FDA authorises new long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 ​​​​On 8th December, [...]

Tower Mains Weekly Newsletter Industry Updates ICMRA holds high-level meeting on global health emergencies and regulatory approaches ​​​​ On 1st [...]

Tower Mains Weekly Newsletter Industry Updates EMA recommends approval for use of Comirnaty COVID-19 vaccine in children aged 5 to [...]

Tower Mains Weekly Newsletter Industry Updates FDA approves an abbreviated new drug application for vancomycin hydrochloride for injection ​​​​On 18th [...]

Tower Mains Weekly Newsletter Industry Updates EMA recommends authorisation of two monoclonal antibody medicines ​​​​On 11th November, the European Medicines [...]

Tower Mains Weekly Newsletter Company Updates We are delighted to welcome Nicole LeBlanc as QA Associate. Nicole will be conducting audits [...]

Tower Mains Weekly Newsletter Company Updates We are delighted to announce we are exhibiting at the virtual Research Quality Association [...]

Tower Mains Weekly Newsletter Industry Updates European Commission establishes portfolio of the ten most promising treatments for COVID-19 ​​​​On 22nd [...]

Tower Mains Weekly Newsletter Company Updates It’s our birthday! This month Tower Mains celebrates its 20-year anniversary, and we would [...]

Tower Mains Weekly Newsletter Industry Updates MHRA updates guidance on how it involves patients and the public in regulatory decision-making [...]

Tower Mains Weekly Newsletter Industry Updates EMA welcomes new Head of International Affairs ​​On 1st October 2021, the European Medicines [...]

Tower Mains Weekly Newsletter Industry Updates WHO recommends the use of Regeneron and Roche's COVID-19 antibody cocktail ​​On 24th September [...]

Tower Mains Weekly Newsletter Industry Updates FDA issues new Chapter 48 guidance for inspectorial programmes The U.S. Food and Drug [...]

Tower Mains Weekly Newsletter Industry Updates FDA revises guidance on the development of abbreviated new drug applications during the COVID-19 [...]

Tower Mains Weekly Newsletter Company Updates We are delighted to welcome Judith O’Hagan to the Tower Mains team as Senior [...]

Tower Mains Weekly Newsletter Industry Updates MHRA updates its list of investigations and decisions carried out on advertising of medicines  On 27th August [...]

Tower Mains Weekly Newsletter Industry Updates FDA updates Pfizer-BioNTech COVID-19 vaccine EUA On 22nd August 2021, the U.S. Food and [...]

Tower Mains Weekly Newsletter Industry Updates  FDA authorises additional COVID-19 vaccine dose for certain immunocompromised individuals  On 12th August 2021, the U.S. Food and Drug Administration (FDA) amended the emergency [...]

Tower Mains Weekly Newsletter Company Updates We are delighted to welcome Naomi Ervine to the Tower Mains team as Senior [...]

Tower Mains Weekly Newsletter Industry Updates EMA announces increased manufacturing capacity and supply for Spikevax COVID-19 vaccine On 30th July [...]

Tower Mains Weekly Newsletter Industry Updates FDA updates its FDA COVID-19 response summary On 23rd July 2021, the U.S. Food [...]

Tower Mains Weekly Newsletter Company Updates  We are delighted to be able to offer bursary places on our next virtual [...]

Tower Mains Weekly Newsletter Industry Updates EMA publishes highlights from its Pharmacovigilance Risk Assessment Committee (PRAC) meeting On 9th July [...]

Tower Mains Weekly Newsletter Industry Updates MHRA publishes new Delivery Plan centred on putting patients first On 4th July 2021, [...]

Tower Mains Weekly Newsletter Industry Updates FDA issues EUA for COVID-19 treatment On 24th June 2021, the U.S. Food and [...]

Tower Mains Weekly Newsletter Company Updates We are delighted to welcome Robbie Boyle to the Tower Mains team as Senior QA Associate.   [...]

Tower Mains Weekly Newsletter Industry Updates FDA warns public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for [...]

Tower Mains Weekly Newsletter Industry Updates FDA posts update to the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page [...]

Tower Mains Weekly Newsletter Industry Updates MHRA approves one-dose Janssen COVID-19 vaccine On 28th May 2021, the Medicines and Healthcare [...]

Tower Mains Weekly Newsletter Company Updates We are delighted to welcome Greta Čepanonyté to the Tower Mains team as QA [...]

Tower Mains Weekly Newsletter Company Updates It's International Clinical Trials Day and the Tower Mains team would like to show [...]

Tower Mains Weekly Newsletter Company Updates Tower Mains will be hosting a webinar on the 18th of May on the [...]

Tower Mains Weekly Newsletter Company Updates On the 18th of May, Tower Mains will be hosting a webinar on the [...]

Tower Mains Weekly Newsletter Industry Updates EC approves GSK’s JEMPERLI (dostarlimab), the first anti-PD-1 therapy approved for endometrial cancer The [...]

Tower Mains Weekly Newsletter Industry Updates New ISO Standard addresses Medical Device Labelling A new ISO Standard on Medical Device [...]

Company Updates We are delighted to announce that we will be offering an Introduction to ICH GCP (R2) Training Course [...]

Company Updates Over the past few weeks, we’ve been sharing our QMS plans, and insights, and it’s now time you [...]

Company Updates From 1st-10th April, our Senior Associate Maxim Bunimovich will be taking part in the 'New Clinical Stars' project, [...]

Company Updates We are delighted to announce that our Managing Director Andrew Waddell and Head of Quality Assurance Shona Ross, [...]

Company Updates We are delighted to announce that exciting Clinical and Quality Assurance opportunities have arisen within the Tower Mains [...]

Company Updates We are delighted to announce that Colin MacDonald PCQI, LRSC, APM will be joining the Tower Mains team [...]

Medicines and Healthcare products Regulatory Agency (MHRA) MHRA publishes GCP inspection metrics report On 15th February 2021, the MHRA published [...]

For your information this will be the last monthly issue of Pharma News. Going forward we will have weekly news [...]