Public Assessment Report on improving information regarding addiction, dependence, withdrawal, and tolerance for gabapentin, pregabalin, benzodiazepines, and z-drugs.
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List of Field Safety Notices from 25 to 29 August 2025.
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Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing stability studies.
Guidance: International Recognition Procedure
How to use the procedure for medicines licensing applications.
MHRA launches Route B notification pilot as part of clinical trials regulations rollout
The pilot will help sponsors prepare for a new substantial modifications process under upcoming regulations, with responses delivered within 14 days.
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Guidance on the deadlines for initial and response submissions.
Field Safety Notices: 6 October to 10 October 2025
List of Field Safety Notices from 6 October to 10 October 2025.
