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I would like to request for Module 2.4, Module 2.5, submitted for Glycopyrronium Bromide 1 mg/5 ml Oral Solution, MAH: Strides Pharma Uk Ltd. (PL13606/0339).
Published: 4 March 2026
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Thank you for that information, it is really helpful. Please can you send some further details about the three incidents? We are seeking information on product brand and details regarding the incident. E.g. Were the products being used in accordance with guidance etc.
Published: 4 March 2026
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The links below will provide further clarification. I am interested in Clinical Scientists and Biomedical Scientists. https://www.england.nhs.uk/wp-content/uploads/2020/10/clinical-science-full-consultation.pdf https://www.england.nhs.uk/wp-content/uploads/2020/10/biomedical-science-consultation-summary.pdf
Published: 4 March 2026
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In your response about safe endotoxin limits, answer 3 you explained "This proposal being discussed was to harmonise the K value for intrathecal and intravenous routes and to introduce a K value for an epidural route." Specialist Pharmcay serivce states https://www.sps.nhs.uk/articles/choosing-an-injectable-medicine-for-intrathecal-administration/ USP Chapter <727> states that “Compounded Sterile Preparations (CSPs) administered epidurally should have the same endotoxin limit as that of intrathecally administered CSPs”. As this aligns with the (unwritten) MHRA expectation that “if tested, epidural solutions would conform to the standards for intrathecals” it would be prudent to adhere to this position. Ther is therefore in place a K value for the epidural route and it tracks the intrathceal route. The SPS page cited explains Endotoxin Limit (EL) = K / M Where K is: • 5 IU/kg of body weight for any parenteral route of administration other than intrathecal, which is the threshold pyrogenic dose of endotoxin per kg of body weight. • 0.2 IU/kg of body weight for intrathecally administered products. Where M is: • the maximum recommended bolus dose of drug per kg of body weight, or • the maximum total dose administered per hour, for injections to be administered at frequent intervals or by continuous infusions For intrathecal administration, the maximum permissible endotoxin dose is 25 x less than for the same product administered via the IV route. This estimate can be used as part of an initial assessment to determine whether an injectable medicine licensed for parenteral use is likely to be suitable for administration by the intrathecal route. 1. as you state the limits are not increasing, please confrim that "harmonise" in your reply means "leveling down" intravenous safe limit to the the current K value used for intrathecal route. 2. If harmonise does not mean leveling down but leveling up , please provide a link to the safety evidence that justifies MHRA policy change for levelling up intrathecal dosing levels to intravenous levels 3. Please provide internal MHRA justification for MHRA altering its "unwritten rule" if the proposed new rule is not to codify the exisitng epidural parity with intrathecal administration 4.. If this harmonisation drive is a general leveling up please explain why it is being promoted specifically in view of well known difficulties and expense invoived of detecting masked endotoxin/ and low endotoxin recovery associated with mRNA and saRNA LNPs cultured in eschrichia coli, and given leveling up i this way manifestly contradicts the fundamental Regulatory "precautionary pronciple", the ethical premise of primum non nocere.
Published: 4 March 2026
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Under the Freedom of Information Act 2000, the Executor Office acting for the Estate of THOMAS BARRY WILLIAMS™ makes the following request for information. 🔹 1. Use of Behavioural Frameworks in Public Health Policy Please provide all documents, communications, guidance notes, training materials, and internal references from 2015 to present that: a) Reference Kurt Lewin’s “Unfreezing–Changing–Refreezing” behavioural model b) Refer to the Stanford Research Institute’s 1974 publication “Changing Images of Man” c) Discuss or implement behavioural change strategies involving crisis induction, cognitive dissonance, or public compliance conditioning d) Have been shared with, or received from, the Behavioural Insights Team (aka “Nudge Unit”), GCS Behavioural Science Team, or any external psychological consultancy involved in influencing medical uptake or public health decisions. Handling of Contradictory and Destabilising Messaging Please provide internal policy documents, reviews, and staff instructions addressing: a) Public communication involving contradictory health advice or rapid reversals of medical policy b) Risk assessments conducted prior to issuing shifting or inconsistent guidance (e.g. masks, injection safety, post-vaccination transmission risks) c) Psychological evaluations (if any) on the impact of contradiction and confusion on public trust and mental health d) Any ethical reviews or harm assessments relating to the promotion of fear, coercion, or emergency urgency tactics used to influence medical decisions. Definition and Avoidance of Gaslighting Please disclose: a) The MHRA’s working definition of gaslighting as it relates to institutional conduct b) Any staff training or internal policies in place to prevent gaslighting-type behaviour when engaging with the public or press c) Documentation of any complaints or concerns received from the public or whistleblowers regarding emotional or psychological harm caused by MHRA communications or endorsements d) Review outcomes or remedial actions taken following such reports (if any). Vaccine Approval, Emergency Use, and Behavioural Framing. a) Please provide internal correspondence relating to the decision to grant temporary/emergency authorisation for mRNA or novel platform-based products (Pfizer, Moderna, AstraZeneca) b) Please include any references to behavioural impact, anticipated public resistance, or plans to “nudge” public trust toward rapid uptake c) Disclosure of discussions surrounding risk/benefit communication strategy and how potential adverse events were planned to be framed or handled publicly d) Any references to shifting the public’s “image of science,” “trust in institutions,” or “perceived risk of not complying”. Internal Review and Harm Response Please confirm: a) Whether any internal reviews have been conducted into psychological harm, confusion, or medical coercion caused by MHRA-endorsed policies b) Whether any MHRA official or staff member has raised concern internally about public trauma, loss of trust, or cognitive destabilisation resulting from these campaigns c) Whether your organisation has collaborated with behavioural psychologists or perception management experts to shape vaccine communication or compliance strategy d) Whether any individuals within MHRA have declared conflicts of interest relating to psychological operations, defence, or behavioural research. This request is made in the public interest to assess whether the MHRA’s health guidance, policy enforcement, and medical licensing strategy reflect principles of scientific integrity, or whether it has engaged in behavioural conditioning indistinguishable from psychological manipulation or trauma induction.
Published: 4 March 2026
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I'm writing to request all available GPvP inspection reports for inspections conducted from 01 Nov 2023 to 30 Jun 2024.
Published: 4 March 2026
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Please would you provide me with a list of software products, whether qualified by their manufacturer or not as medical devices, created or active in the period 1st January 2024 to 19th January 2026, listing: • the name of the manufacturer, • the name of the product, • the level of enforcement action (compliance/ suspension/ prosecution), • the dates of opening and closing the enforcement action • URL of any relevant Field Safety Notice (on your Filecamp SaaS).
Published: 4 March 2026
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Under the freedom of information act I request the information about the astrazenca COVID-19 vaccine and how may cause stroke in people with blood group o.
Published: 4 March 2026
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I would like to have access to any inspection findings concerning clinical trial documentation which concern: - Completeness: missing or incomplete documentation - Quality: miscataloguing of documentation - Timeliness: delays in capturing trial documentation - Site Personnel: any findings concerning documentation related to personnel involved in the planning and execution of the trial - Monitoring Visits: any findings related to the planning and execution of monitoring visits and their related documentation
Published: 4 March 2026
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Please could you confirm what adverse events/ reactions are associated with AstraZeneca batches PW46674 and PV46696; how many vaccinations were given in the UK from both batches and how many people (to date) have reported adverse reactions to either batch? Thank you for your help with this request.
Published: 4 March 2026
