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Top Industry News
- TGA- Biologicals regulatory framework changes from 1 July 2018
- TGA- Medicine labels: Guidance on TGO 91 and TGO 92
- MHRA- Good laboratory practice (GLP) for safety tests on chemicals (updated)
- FDA- Nonclinical Studies and Labeling Recommendations Guidance for Industry : Oncology Therapeutic Radiopharmaceuticals
- Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
- MHRA- Good pharmacovigilance practice (GPvP) (updated)
- TGA- Changeover to Therapeutic Goods Advertising Code 2018 effective from 1 January 2019
- FDA Finalizes Guidance on Biosimilar User Fees Under BsUFA II
- TGA- Medicine GMP - revised fees and charges effective 1 July 2018