Cómo Crear PNTs a Prueba de Auditorías: La Lista de Verificación Definitiva de QA

Escribir un Procedimiento Normalizado de Trabajo (PNT / SOP) no es solo plasmar palabras en un papel; es construir un escudo de cumplimiento para tu planta. Un PNT mal redactado es la causa directa de desviaciones, errores humanos y dolores de cabeza durante las auditorías de la #MHRA o la #FDA. 🛡️Ya sea que estés redactando un procedimiento desde cero o revisando una actualización, aquí…

https://www.frontlifesciences.com/como-crear-pnts-a-prueba-de-auditorias-la-lista-de-verificacion-definitiva-de-qa/

Cómo Crear PNTs a Prueba de Auditorías: La Lista de Verificación Definitiva de QA - Front Life Sciences

Escribir un Procedimiento Normalizado de Trabajo (PNT / SOP) no es solo plasmar palabras en un papel; es construir un escudo de cumplimiento para tu planta. Un PNT mal redactado es la causa directa de desviaciones, errores humanos y dolores de cabeza durante las auditorías de la #MHRA o la #FDA. 🛡️Ya sea que estés […]

Front Life Sciences

MHRA to offer early review of non-animal data. The Medicines and Healthcare products Regulatory Agency (MHRA) will offer early review of non-animal data in a decision supporting the government’s strategy to reduce animal testing in drug development.

The move is intended to help drug developers make greater use of New Approach Methodologies (NAMs),
https://www.ddw-online.com/mhra-to-offer-early-review-of-non-animal-data-41080-202603/

#Animaltesting
#MHRA #Science
#Newapproachmethodologies #nams
#Regulatory #videnskab #dyreforsøg

MHRA to offer early review of non-animal data  

The Medicines and Healthcare products Regulatory Agency (MHRA) will offer early review of non-animal data in a decision supporting the government’s strategy to reduce animal testing in drug development.  

Drug Discovery World (DDW)

Side effects wrongly listed as "uncommon" in a Parkison's medication.

The Chair of the Commons Health Select Committee is not happy and wants government action against the UK's drug safety regulator, the MHRA.

https://www.bbc.co.uk/news/articles/ckg0xxwn041o

#MHRA #Pharma #Medicine #NHS

'He would have been horrified' - error in drug warnings 'misled' families

Warnings for dopamine agonist drugs are to be reviewed after BBC identified an error in patient leaflets.

BBC News

The MHRA's 'AI Airlock' is apparently hitting warp speed on AI tools for patient care, aiming to slash agonizing wait times for diagnoses. From clinical note-takers to advanced cancer diagnostics, it's all hands on deck.

Just remember, 'it works on my machine' takes on a whole new meaning when dealing with actual humans. What kind of rigorous testing do you think these medical AIs *really* need?

#AIforHealth #DigitalHealth #MHRA #HealthcareAI #TechNews
https://www.artificialintelligence-news.com/news/mhra-fast-tracks-next-wave-of-ai-tools-for-patient-care/

MHRA issues urgent safety guidance for GLP-1 skinny jab medicines like Ozempic and Mounjaro. Use only under medical supervision to avoid risks. Read more: https://www.thesentinelcurrent.com/health-skinny-jabs-safety-risks/ #GLP1 #SkinnyJabs #MHRA #HealthSafety #WeightLoss
Skinny Jabs GLP-1: Urgent Safety Alert

Learn critical MHRA guidance on skinny jabs medicines like Ozempic and Mounjaro, including contraception risks and safe use.

The Sentinel Current

Next to CE certification according to #MDR (#EU 🇪🇺), the MediBrite is also registered as a medical device in the Medicines & Healthcare products Regulatory Agency (#MHRA) for its clinical use in the #UK 🇬🇧

🟢 #Neuroimaging #fNIRS #NIRS

#MaineResists! #Maine officials refuse to sign #Trump agreement on #TransgenderAthletes

The U.S. Department of Health and Human Services said earlier this month that it would give state and local officials in Maine 10 days to sign a proposed agreement banning transgender athletes or the state would risk referral to the U.S. Department of Justice.

by Rachel Ohm, March 27, 2025

"Leaders of the Maine Principals’ Association and Greely High School say they will not sign a proposed agreement from the Trump administration requiring Maine to stop allowing transgender athletes to compete in girls’ high school sports.

"The U.S. Department of Health and Human Services gave the Maine Department of Education, Maine Principals’ Association and Greely High School 10 days to sign a proposed resolution agreement in response to its findings that Maine violated federal #TitleIX law by allowing a transgender high school student to compete in a girls’ indoor track championship last month.
Thursday marks 10 days since the Maine entities were notified of #DHHS’ findings and presented with a proposed resolution.

"'In a letter to the community Thursday, the school board of School Administrative District 51, which includes Greely High School, said the district will not sign the agreement.

"'As stated during our Board meeting on March 6th, MSAD 51 will continue to follow state law and the #MaineHumanRightsAct (#MHRA),' the letter said. 'Compliance with the proposed (agreement) would be a violation of current Maine law.'

"A spokesperson for the #MPA said Wednesday it also will not sign the agreement. The MPA also sent a letter to DHHS last week saying the federal agency doesn’t have any jurisdiction over the private non-profit organization and asking it to dismiss its finding of a violation.

"'The Maine Principals’ Association is bound by the law, including the Maine Human Rights Act (MHRA), which our participation policy reflects,' the MPA said in a statement Wednesday. 'We are unable to sign any resolution agreement that would mandate we create a new policy that would violate the law and MHRA. As such, we have not signed and will not sign the resolution agreement sent by the federal Department of Health and Human Services.'"

[...]

"The Trump administration has said it could refer the findings to the U.S. Department of Justice if the agreement is not signed. U.S. Attorney General Pam Bondi has also threatened to sue Maine if the state refuses to comply with Trump’s executive order calling for a nationwide ban on transgender student-athletes.

Read more:
https://www.pressherald.com/2025/03/27/maine-officials-refuse-to-sign-trump-administrations-proposed-agreement-on-transgender-athletes/

Archived version:
https://archive.md/itxCl
#Resistance #ResistAuthoritarianism #TransRightsAreHumanRights #TransgenderRights #TrumpIsABully #USPol #District13

Maine officials refuse to sign Trump agreement on transgender athletes

The Maine Principals' Association and Greely High School said it would violate Maine law for them to sign the agreement requiring the barring of transgender athletes.

Press Herald
Resonator -a medical gizmo that cures nothinng. Why hasn't the #MHRA banned it? A failure of regulation.
https://www.dcscience.net/2025/02/11/resonators-and-kindred-frauds/
Resonators and kindred frauds

Googling ‘bioresonance therapy’ produces a large number of hits.  One of the first comes from the Oxford Chiropractic Clinic, which says “Bioresonance is one of the most exciting innovati…

DC's Improbable Science
Deadline looms for post-Brexit label changes for UK meds

The MHRA has reminded pharma companies that from 1st January all medicines sold in the UK will have to comply with new labelling requirements

pharmaphorum