Blog
RSS FeedPosted by Michael Wonder on 30 Apr 2018
Update of EU recommendations for 2018/2019 seasonal flu vaccine composition
30 April 2018 - Update to recommendations issued in March 2018. ...
Posted by Michael Wonder on 27 Apr 2018
FDA moves to encourage A.I. in medicine, drug development
26 April 2018 - It is establishing a new incubator focused on health technology. ...
Posted by Michael Wonder on 26 Apr 2018
Updated rules for clinical development of vaccines
26 April 2018 - EMA launches public consultation on revised guideline on clinical evaluation of vaccines. ...
Posted by Michael Wonder on 12 Apr 2018
FDA finalises guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests
12 April 2018 - The agency is leveraging new tools and policies to advance the creation of innovative genetic and genomic-based ...
Posted by Michael Wonder on 10 Apr 2018
ICER publishes guidance on improving the development and use of real world evidence for drug coverage and formulary decisions
10 April 2018 - The ICER, in collaboration with the Office of Health Economics, has released two new white papers to ...
Posted by Michael Wonder on 20 Mar 2018
FDA, industry ponder changes to clinical trials for rare disease treatments
19 March 2018 - FDA statisticians pondered changing how the agency uses statistics to approve drugs for rare disease at ...
Posted by Michael Wonder on 08 Mar 2018
US cancer network recommending expensive drugs based on weak evidence, study finds
8 March 2018 - Study raises concerns about National Comprehensive Cancer Network, which publishes guidelines for American oncologists. ...
Posted by Michael Wonder on 28 Feb 2018
Europe follows FDA with plans to help early Alzheimer's drugs
28 February 2018 - European regulators are following in the footsteps of the U.S. Food and Drug Administration with plans ...
Posted by Michael Wonder on 21 Feb 2018
American Society of Clinical Oncology statement: biosimilars in oncology
21 February 2018 - As many biosimilars come to market in the next several years, their use in oncology will play ...
Posted by Michael Wonder on 21 Feb 2018
Mandatory requirements for an effective application
21 February 2018 - Applicable for applications lodged from 9 February 2018. ...
Posted by Michael Wonder on 19 Feb 2018
RMAT vs. breakthrough vs. fast track: companies seek clarity on FDA draft guidance
19 February 2018 - Industry groups BIO, the Alliance for Regenerative Medicine and the International Society for Cellular Therapy, as well ...
Posted by Michael Wonder on 16 Feb 2018
FDA opens new path for Alzheimer's treatments
16 February 2018 - Draft guidance comes after Merck failure, years of others. ...
Posted by Michael Wonder on 03 Feb 2018
Strengthened guidance on follow-up and risk management for ATMP developers
2 February 2018 - Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultation ...
Posted by Michael Wonder on 29 Jan 2018
Doctors are cleared to prescribe cheaper drug for wet AMD
24 January 2018 - Doctors who prescribe bevacizumab (Avastin) for age related macular degeneration (AMD) will “not raise fitness to ...
Posted by Michael Wonder on 11 Jan 2018
New guidance: When can the FDA refuse to file NDAs and BLAs?
10 January 2018 - According to US FDA regulations, the regulatory agency may refuse to file a new drug application ...