What people are saying - Write a review
We haven't found any reviews in the usual places.
Chapter TwoThe choicesto go it alone or seek
Chapter FiveThe evaluation process for applications
Chapter SixAustralian Drug Evaluation Committee
7 other sections not shown
acceptance access to unapproved ADEC meeting ADR reports ADRAC Adverse Drug Reactions agency APMA appropriate arrangements assessment Australian evaluation basis bioequivalence changes Chapter chemical entities clinical evaluators clinical trials Community Services considered consumers costs countries CTN scheme data requirements decision delays delegation dosage forms Drug Evaluation Branch effective efficacy ensure evaluation process existing external evaluators Government guidelines harmonisation Housing and Community IECs individual patient data industry life-threatening manufacturer marketed in Australia marketing applications marketing approval Minister National Manager NHMRC organisation orphan drug PBAC performance Peter Staples Pharmaceutical Benefits Branch Pharmaceutical Benefits Scheme Pharmaceutical Chemistry practitioners prescriber priority product information proposed recommend regulation regulation of therapeutic regulatory relevant request responsibility role safety Secretariat service drugs special access sponsor companies staff standards Subcommittee submission Sweden target TGA's Therapeutic Goods Act Therapeutic Goods Administration tion treatment unapproved drugs