PBAC Public Summary Documents - July 2019 meeting

1 November 2019 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the July 2019 PBAC ...

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PBAC Public Summary Documents - May 2019 meeting

1 November 2019 - The Public Summary Documents from the May 2019 PBAC intracycle meeting are now available. ...

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Annual performance statistics report: July 2018 to June 2019

21 October 2019 - At 30 June 2019 there were 88,788 therapeutic goods on the ARTG, including 31,987 new products added ...

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EMA publishes agenda for 14-17 October CHMP meeting

14 October 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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ICER releases updated draft evidence report on rheumatoid arthritis therapies

11 October 2019 - Public comment period extended through 8 November 2019; public meeting now to take place on 9 December ...

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High health care costs suggest review is needed: report

8 October 2019 - The federal government’s annual $6 billion spend on the health insurance rebate could be redirected to ...

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FDA issues draft guidance on patient-focused drug development: methods to identify what is important to patients

30 September 2019 - Today the U.S. FDA issued a draft guidance on Patient-Focused Drug Development: Methods to Identify What Is ...

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1 October 2019 price disclosure confirmed prices

30 September 2019 - Confirmed 1 October 2019 prices resulting from the 2019 October Cycle of Price Disclosure have now been ...

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ICER releases draft evidence report on rheumatoid arthritis therapies

26 September 2019 - Public comment period now open until 24 October 2019; requests to make oral comment during public ...

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Interacting with the FDA on complex innovative trial designs for drugs and biological products

20 September 2019 - This document provides guidance to sponsors and applicants on interacting with the FDA on complex innovative trial ...

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EMA publishes agenda for 16-19 September CHMP meeting

13 September 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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ICER publishes evidence report on additive cardiovascular disease therapies

12 September 2019 - Pricing of rivaroxaban and icosapent ethyl aligns well with treatments’ benefits for patients; expert roundtable will discuss ...

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ICER releases draft evidence report on diabetes therapies

11 September 2019 - Public comment period now open until 8 October 2019; Requests to make oral comment during public meeting ...

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Bad diagnosis: health care system muddled, lacking leadership major report finds

3 September 2019 - The review is being led by former prime minister Helen Clark's chief of staff, Heather Simpson. ...

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Academics and consumer groups protest FDA plan to summarise review documents

29 August 2019 - A Food and Drug Administration proposal to substitute detailed reviews of new drugs written by specific ...

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