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Australian Industry Concerned Over Comparator Drug, Differing Evidence Levels, As New PBS Guidance Draws Near

 
• By Ian Schofield

The revised guidelines for making submissions to list drugs on the Australian Pharmaceutical Benefits Scheme have raised industry and patient concerns over the criteria for choosing the comparator drug, how to assess differing levels of evidence, and the need for more patient and clinician input.

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The review of the Australian guidelines on submitting medicines for inclusion on the Pharmaceutical Benefits Scheme is expected to be completed in November, after which a set of workshops will be held to help companies planning to file drugs for reimbursement under the new guidance, according to the Department of Health.

The review, which began in April 2015, is intended to ensure assessment processes at the Pharmaceutical Benefits Advisory Committee are...

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Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 
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