Blog
RSS FeedPosted by Michael Wonder on 27 Jun 2018
New from CADTH: procedural guidelines and a streamlined therapeutic review framework
27 June 2018 - Recent changes continue to strengthen the Pharmaceutical Reviews portfolio and help CADTH adapt quickly to the changing ...
Posted by Michael Wonder on 25 Jun 2018
Statement by FDA Commissioner on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components
25 June 2018 - Over the past decade, we’ve seen a growing interest in the development of therapies derived from marijuana ...
Posted by Michael Wonder on 23 Jun 2018
Depression in adults: campaigners and doctors demand full revision of NICE guidance
20 June 2018 - A coalition of mental health organisations and individual clinicians has described the latest draft guidelines on ...
Posted by Michael Wonder on 21 Jun 2018
FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies
21 June 2018 - Today, the agency withdrew the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September ...
Posted by Michael Wonder on 19 Jun 2018
Modernising the orphan designation process
19 June 2018 - The EMA has launched a new secure online portal for orphan designationExternal link icon applications. ...
Posted by Michael Wonder on 19 Jun 2018
Commentary on the EMA Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products
19 June 2018 - The EMA published in July 2017 a guideline for first‐in‐human drug studies. ...
Posted by Michael Wonder on 12 Jun 2018
Statement from FDA Commissioner on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections
12 June 2018 - The increase in serious antimicrobial drug resistant infections is a critical public health concern and a ...
Posted by Michael Wonder on 12 Jun 2018
Statement from FDA Commissioner on new efforts to advance medical product communications to support drug competition and value-based health care
12 June 2018 - We’re living in a time of unparalleled scientific advancement. Innovative medical treatments continue to be developed ...
Posted by Michael Wonder on 06 Jun 2018
FDA’s new efforts to advance biotechnology innovation
6 June 2018 - Scientific advances in biotechnology, such as genome editing and synthetic biology, hold enormous potential to improve human ...
Posted by Michael Wonder on 05 Jun 2018
FDA drafts new guidance on formal meetings between FDA, biosimilar sponsors
4 June 2018 - The US FDA has released new draft guidance on formal meetings between biosimilar sponsors and the ...
Posted by Michael Wonder on 04 Jun 2018
English translation of IQWiG’s updated General Methods now available
4 June 2018 - New chapters on HTA reports addressing topics proposed by the public and on the assessment of ...
Posted by Michael Wonder on 24 May 2018
New melanoma guidelines recommend $150,000 a year treatment that’s not subsidised
25 May 2018 - Sweeping changes to medical guidelines for melanoma could halve the rate at which the cancer recurs ...
Posted by Michael Wonder on 20 May 2018
3L, 5L, What the L? A NICE conundrum
20 May 2018 - For many years, NICE has recommended use of the EQ-5D-3L and its value set for the UK. ...
Posted by Michael Wonder on 09 May 2018
Outcomes of the consultation on the draft list of permitted indications
8 May 2018 - On 6 March 2018, the TGA implemented a list of permitted indications for medicines listed under Section ...
Posted by Michael Wonder on 08 May 2018
Two years of PRIME
7 May 2018 - Driving innovation to where it is most needed. ...