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Please confirm the total number of suspected reactions in association with GLP-1 receptor agonists indicated (used) for weight management only (NB: please do not include hospitalisations where the indication includes diabetes). Please confirm how many of these suspected reactions reported the hospitalisation of the individual. In addition, please supply details of the ten most common suspected reactions which led to the hospitalisations. How many reports has the MHRA received of pulmonary aspiration during surgical procedures in patients receiving GLP-1 drugs for any indication?
Published: 30 May 2025
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I was wondering if you had any available iDAPs information on the Shingrix vaccine please? I have a patient who is enquiring about a possible link between the vaccine and developing Bell's palsy, there is no report of this as a potential side effect within the published SPC.
Published: 30 May 2025
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Could you please share full latest WDA (GDP) & MS/GMP/MIA inspection report: (1) ACTIVE PHARMA SUPPLIES LIMITED, UNIT 2, FORWARD INDUSTRIAL ESTATE, TALBOT ROAD, LEYLAND, PR25 2ZJ, UNITED KINGDOM (2) ARC PHARMA (UK) LIMITED , UNIT 3, CURO PARK, FROGMORE, ST. ALBANS, AL2 2DD, UNITED KINGDOM (3) SYRI LIMITED, UNIT 4, BRADFIELD ROAD, RUISLIP, HA4 0NU, UNITED KINGDOM (4) VALNEVA SCOTLAND LIMITED, 1 OAKBANK PARK PLACE, MID CALDER, LIVINGSTON, EH53 0TN, UNITED KINGDOM (5) HAMOL LIMITED, NOTTINGHAM SITE, THANE ROAD, NOTTINGHAM, NG90 2DB, UNITED KINGDOM
Published: 30 May 2025
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Yes please could I have the risk management plan for this and the list of adverse affects. If a cost is incurred I will be happy to pay (depending on how much)
Published: 30 May 2025
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Dear Medicines & Healthcare products Regulatory Agency Pursuant to the Freedom of Information Act 2000, in relation to the clinical trial titled "A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors", which has the EudraCT number 2014-002605-38, please provide copies of: 1. A copy of Revised Protocol 7 (dated 20 December 2016). 2. A copy of Revised Protocol 8 (dated 31 July 2017). 3. A copy of the Investigator's Brochure. 4. A copy of the patient informed consent forms. 5. Copies of any minutes or decisions relating to the approval of the trial and/or amendments to the trial protocol. The MHRA approved the protocol on 21 November 2016. The sponsor was Bristol-Myers Squibb International Corporation. Please let us know if you require any further information from us.
Published: 30 May 2025
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on the 7th March you kindly informed me that Aflunov licensed in November 2010 is the predicate vaccine for Incellipan, Adjuvanted Zoonotic Influenza Vaccine Sequirus and Celldemic. According to Regulation 56 of Human Medicines Regulations, you must have licensed the 3 newer vaccines as bioequivalents to ensure "the same qualitative and quantitative composition". You must have done this on the basis of their bioequivalence given the different composition and production process of each vaccine. Please point me to or send me the bioequivalence studies.
Published: 30 May 2025
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Information on side effects of Hepatitis B vaccine, Energix please [personal information].
Published: 30 May 2025
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This is a request for information filed under the FOI Act. Please confirm receipt. 1) According to: https://imedconsultancy.com/lifevac-europe-ltd/ In 2017, the MHRA imposed a temporary restriction on LifeVac, limiting its sales to the care sector, which required LifeVac Europe to meet stringent regulatory demands and reporting requirements for an innovative device intended for an unmet medical need. During this period, Matthew Burton worked tirelessly to help LifeVac Europe meet rigorous regulatory demands, including the preparation of detailed Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) reports on a quarterly basis until significant sufficient data was generated to allow the restrictions to be lifted in June 2023. After this point the device could now be used as intended. Please provide me with copies of all quarterly Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) reports submitted by or on behalf of LifeVac Europe Ltd from August 2017 through June 2023 including all related correspondence. Please redact any confidential and/or proprietary company information, and identify the appropriate statutes justifying each redaction. 2) From https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/667136/Item_07__2017-OB-14__CEOs_Report_Nov_17.pdf LifeVac - We took a number of enquiries about MHRA's regulation of LifeVac, an antichoking device. After liaising with colleagues in Devices, we sent a statement to Huffington Post, Daily Mail, Cambrian News and Sunday Times Ireland. Re: all of the above inquiries (Huffington Post, Daily Mail, Cambrian News and Sunday Times Ireland), please provide me with copies of all related correspondence. Please provide the records in digital format via e-mail if possible. I'm requesting these records for an article I'm reporting on my blog and I have no financial interest in the requested information, therefore this is to request that any fees be waived. If the fee for completing my request exceeds 5 pounds, please obtain my written approval prior to completing this request. Please send the requested records as ready rather than accumulated in a single response. Finally, please include instructions on how I may appeal your response. Thank you for your attention and I look forward to your confirmation of receipt and to receiving the requested records.
Published: 30 May 2025
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1. Before the MHRA outsourced the decisions about whether a scientific experiment on humans with drugs/substances/IMPs is a clinical trial (CTIMP) or not a clinical trial (non-CTIMP) to universities and other bodies, the MHRA used to make these decisions. For 30 of the most recent applications, could you please release a summary of the proposed study (e.g. abstract) and your decision on whether it is a CTIMP or a non-CTIMP, before the MHRA outsourced the decision-making process. 2. How do you monitor the universities that make these decisions and ensure that they are correctly categorising studies as clinical trials, and non-CTIMPs? I'm especially interested to know how you ensure that universities are not unnecessarily, *over*-categorising studies as CTIMPs. 3. Would this hypothetical experiment be a CTIMP or a non-CTIMP: a well known, GMP-manufactured drug is given at a safe dose in a one-off dose, double-blind, placebo-controlled RCT experiment to patients with a mental health condition to study the effects of this drug on an experimental behavioural measure (i.e. not clinical or safety outcome) in the lab. 4. Should the university regulatory bodies who make these decisions now be transparent and publish (1) applications and results; (2) the minutes/ways they make the decisions about specific studies.
Published: 30 May 2025
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1. Before the MHRA outsourced the decisions about whether a scientific experiment on humans with drugs/substances/IMPs is a clinical trial (CTIMP) or not a clinical trial (non-CTIMP) to universities and other bodies, the MHRA used to make these decisions. For 30 of the most recent applications you received before the change in policy, could you please release a summary of the proposed study (e.g. abstract) and your decision on whether it was a CTIMP or a non-CTIMP. 2. How do you monitor the universities that make these decisions and ensure that they are correctly categorising studies as clinical trials, and non-CTIMPs? I'm especially interested to know how you ensure that universities are not unnecessarily, *over*-categorising studies as CTIMPs. 3. Would this hypothetical experiment be a CTIMP or a non-CTIMP: a well known, GMP-manufactured drug is given at a safe dose in a one-off dose, double-blind, placebo-controlled RCT experiment to patients with a mental health condition to study the effects of this drug on an experimental behavioural measure (i.e. not clinical or safety outcome) in the lab. 4. What requirements do you put on universities who now make these CTIMP/non-CTIMP decisions about their transparency of decision-making to researchers? Do you require them to publish previous decisions and how they came to them, if they are asked?
Published: 30 May 2025
