Australian Online Tool To Take Tedium Out Of Identifying New PI
Executive Summary
The TGA says that its new search function to help generic drug sponsors identify new and updated product information will become more valuable over time.
You may also be interested in...
Australia's New Product Info Format For Drugs Kicks In
Drug sponsors in Australia should be preparing their product information (PI) documents in accordance with a new format that came into effect in on Jan. 1. The revised format makes critical clinical information more accessible and aligns the Australian PI format with that of other international regulators.
EMA Probe Finds No Link Between GLP-1s And Suicidal Thoughts & Actions
After reviewing the evidence from non-clinical studies, clinical trials, post-marketing surveillance data and other studies, the European Medicines Agency said there was no need to update the product information for 11 diabetes and weight management drugs.
English Funding For Aquipta Targets AbbVie’s Migraine Drug To 170,000 People
Aquipta is the first oral treatment that NICE has recommended for preventing chronic migraines in the fourth-line setting, and the second oral treatment for episodic migraines in the same setting. The drug has already secured reimbursement in Scotland, Sweden and Israel.