A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: 100 Days of Embracing Gold-Standard Science, Transparency and Common Sense
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Don’t let the heatwave affect your medicines: Three important tips from the MHRA
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FDA Embraces Radical Transparency by Publishing Complete Response Letters
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Government to align with European specifications on high risk in vitro diagnostic devices to reduce regulatory burden
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Don’t let the heatwave affect your medicines: Three important tips from the MHRA
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Common specification requirements for in vitro diagnostic devices
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FDA Encourages Industry Leaders to Streamline, Enhance Product Recall Communications to Safeguard Foods for Infants and Children
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Decision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients
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Access, new active substance and biosimilar work sharing initiatives
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Decision: Human and veterinary medicines: register of licensed manufacturing sites
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Notice: Register of brokers authorised to deal in human medicines
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Decision: Medicines: new manufacturing and wholesale dealer licences
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Notice: Medicines: terminated and cancelled manufacturing and wholesale dealer licences
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Decision: Human and veterinary medicines: register of licensed wholesale distribution sites
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Decision: Orphan registered medicinal products
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Field Safety Notices: 30 June to 4 July 2025
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MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause
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Class 2 Medicines Recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa EL(25)A/34
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Abrysvo▼ (Pfizer RSV vaccine) and Arexvy▼ (GSK RSV vaccine): be alert to a small risk of Guillain-Barré syndrome following vaccination in older adults
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MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Decision: Human and veterinary medicines: register of licensed manufacturing sites
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Notice: Register of brokers authorised to deal in human medicines
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Decision: Medicines: new manufacturing and wholesale dealer licences
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Notice: Medicines: terminated and cancelled manufacturing and wholesale dealer licences
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Decision: Human and veterinary medicines: register of licensed wholesale distribution sites
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.