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The meeting of the Advisory Committee on Medicines (ACM).
The committee's advice was sought on 7 applications under evaluation by the TGA. The applications included:
- one for the registration of a new chemical entity
- one for the registration of a new biological entity
- three seeking extension of indications
- one seeking a major variation to add a new dosing regimen
- one seeking a minor variation to amend the specifications
Members
Membership comprises of professionals with specific scientific, medical or clinical expertise, as well as appropriate consumer health issues relating to medicines.