Life Saving Drugs Program: new lease on life, or on life support?
The Life Saving Drugs Program currently provides subsidised access to patients with rare and life-threatening conditions to essential and very expensive medicines….
What is Happening with the Provisional Approval Pathway?
When the independent review of medicines and medical devices regulation was announced the pharmaceutical sector immediately saw the opportunity for an expediated approval pathway for certain prescription…
New ‘SmPC’ Format for the Australian Product Information
The TGA have published a new form for providing the product information (PI) which means more work for regulatory teams but an enhancement of the quality use of medicines for Australian patients….
With a greater recognition of the importance of nutritional support in medical therapy and improved technology, the “food for special medical purposes” market is currently…
Patient support program – the key driver of better health outcomes
Pharmaceutical companies play a key role in supporting the quality use of medicines through patient focused programs. These programs are designed to aid compliance and lifestyle choices….
Warning: This medical device literature review may contain traces of LBS
With the release of new clinical evidence guidelines for medical devices, sponsors and manufacturers will be expecting some further guidance on the structure, content and quality of their clinical evaluation…