Pharmaceutical

shutterstock_1074052646 (1)

That’s ODD: can your medicine benefit from incentives for treating rare disorders?

By Vergel Manalo | 31 July, 2020
The time, resources, and costs of developing and marketing medicines are extensive – putting treatments for rare disorders at a distinct disadvantage since the potential return on investment is limited...
shutterstock_181476422 (1)

Addendum to TGA Deadlines: Medicine Labelling Compliance and COVID-19

By Reena Patel | 19 June, 2020
As described in the Upcoming TGA Deadlines for Medicine Labelling and Product Information Reform article the transition period for Australian Medicines Packaging Reform concludes on 31 August 2020. As a...
Medicine packaging

Upcoming TGA Deadlines for Medicine Labelling and Product Information Reform

By Reena Patel | 18 May, 2020
2020 was flagged to be a big year for TGA Sponsors of Medicines with two long-standing milestones on the horizon. Whilst there is no doubt this won’t be a year...

Search

Recent Posts

That’s ODD: can your medicine benefit from incentives for treating rare disorders?

Jul 31, 2020

TGA published review of safety and performance issues in Medical Device software

Jul 29, 2020

Risk Management ISO Standards – ISO 14971: 2019 and ISO TR 24971: 2019.

Jul 22, 2020

Harmonised Standards for MDR? CEN/CENELEC say “Non”

Jul 2, 2020

FAQs Regarding the Australian R&D Tax Incentive and Regulatory Services

Jul 1, 2020

Addendum to TGA Deadlines: Medicine Labelling Compliance and COVID-19

Jun 19, 2020

Categories

Categories

Archives

Archives

Archives

Tags

510(k) APAC Australia Biocompatibility Brexit CE CE Certificates clinical trials coronavirus COVID19 de novo distribution EU Europe FDA GHTF Harmonization IMDRF IVD IVDD IVDR MDD MDR MDSAP medical device Medical Device Regulations medical devices medicines MHRA New Zealand Notified Bodies Pharmaceutical PMA PMDA postmarket private health insurance Quality Systems Reform regulatory Reimbursement SaMD Software standards TGA UDI