7 June 2018 - On 1 July 2017 amendments to the Therapeutic Goods Regulations 1990 (the Regulations) came into effect that ...
4 June 2018 - The staff of the FDA’s Center for Drug Evaluation and Research (CDER) always tries to utilise cutting-edge ...
24 May 2018 - Between 2009 and 12, the FDA approved 97 new drugs and biologics for 106 indications with at ...
12 April 2018 - In 2012, Congress created the breakthrough-therapy designation to expedite the testing and approval by the FDA of ...
3 April 2018 - The TGA has maintained a high level of activity while also progressing regulatory reforms over the reporting ...
20 March 2018 - As part of the Government's response to the Review of Medicines and Medical Devices Regulation, the TGA ...
22 February 2018 - A bill passed by the Senate would sharply curtail the FDA’s oversight of access to investigational drugs. ...
7 February 2018 - The FDA recently made long-awaited progress toward protecting patients from interventions involving human cell- and tissue-based products ...
5 February 2018 - Standard deviations and standard errors are reported routinely in statistical analyses, but the distinction between them is ...
19 January 2018 - One year ago, 19 January 2017, FDA officially launched the Oncology Center of Excellence to leverage the ...
23 January 2018 - 92 medicines recommended for approval, including 35 with a new active substance. ...
16 January 2018 - To encourage innovation and provide patients with access to the latest safe and effective medical technologies, we ...
10 January 2018 - In 2017, FDA’s Center for Drug Evaluation and Research approved many new drugs never before marketed in ...
8 January 2018 - The Center for Biologics Evaluation and Research worked diligently during Fiscal Year 2017 to fulfil its ...
5 December 2017 - New FDA guidance will make it easier for generic companies to get drug-device combination products approved. ...