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EMA Draft Guideline on Quality of Radiopharmaceuticals
Radiopharmaceuticals present unique quality challenges due to their radioactive nature, short shelf lives, and frequent need for on-site or near-patient preparation. To reflect scientific and technological advances since the original 2007 guideline, the European Medicines Agency has released the draft Guideline on quality of radiopharmaceuticals – Revision 2 for public consultation. Adopted by CHMP in December 2025, this revision provides updated expectations for quality doc
Sharan Murugan
Dec 13, 20252 min read
USFDA Draft Guidance: Radiopharmaceutical Dosage Optimization and Overall Survival Assesment in Oncology Clinical Trials
On 18th August 2025, the U.S. Food and Drug Administration (FDA) recently published two important draft guidance documents that aim to...
Sharan Murugan
Aug 19, 20252 min read
Swissmedic Guidance on Product Information for Human Medicinal Products
Swissmedic, the Swiss Agency for Therapeutic Products, has introduced its updated guidance on " Product Information for Human Medicinal...
Sharan Murugan
Nov 16, 20242 min read
Swiss Medic Guidance: Minimising the Risk of TSE and Authorisation of Radiopharmaceuticals
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (26 May 2023) the "Guidance document...
Sharan Murugan
May 28, 20232 min read