Professor James Levine: When policy becomes medicine
How regulation can spark life-saving innovation.
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17th Annual Sentinel Initiative Public Workshop – 11/06/2025
The U.S. Food and Drug Administration, under a cooperative agreement with the Duke-Margolis Institute for Health Policy, is hosting the 16th Annual Sentinel Initiative Public Workshop on November 6, 2025 -
Lupin Limited Unit 3 – 07/17/2025
Lupin Limited Unit 3 – 07/17/2025. Country: India. Record Type: 483 -
Hetero Labs Limited, Unit-IX – 09/26/2025
Hetero Labs Limited, Unit-IX – 09/26/2025. Country: India. Record Type: 483 -
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Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication
FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices; asks for reports of injuries related these devices -
The new Innovative Licensing and Access Pathway welcomes first investigational products
Developers work with the NHS, the medicines regulator and the UK health technology assessment bodies from the early stages of clinical development, as part of the Innovative Licensing and Access Pathway.
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Advancing Generic Drug Development: Translating Science to Approval 2025 – 10/07/2025
Join us for the 2025 Advancing Generic Drug Development Workshop! FDA experts will demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. -
100 years of protecting patients through biological standards for medicines
The MHRA produces over 95 per cent of the World Health Organization’s (WHO) biological standards.
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FDA approves new treatment for acromegaly, a rare endocrine disorder
The U.S. Food and Drug Administration (FDA) approved Palsonify (paltusotine) tablets to treat adults with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. -
Health and Natural Beauty USA Corp. – 700187 – 07/28/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Field Safety Notices: 6 October to 10 October 2025
List of Field Safety Notices from 6 October to 10 October 2025.