Blog
RSS FeedPosted by Michael Wonder on 10 May 2019
Taxpayers are funding expensive drug development, report says
10 May 2019 - The Dutch government invests tens of millions of euros every year in small biotech companies which ...
Posted by Michael Wonder on 02 May 2019
The antibiotic industry is broken
2 May 2019 - Take inspiration from the entertainment industry. ...
Posted by Michael Wonder on 02 May 2019
FDA's efforts to advance the development of gene therapy
1 May 2019 - Gene therapy has been on the horizon for several decades and has now become a reality in ...
Posted by Michael Wonder on 20 Apr 2019
FDA's efforts to advance the development of biologics
17 April 2019 - The FDA’s Center for Biologics Evaluation and Research is working at the forefront of 21st century ...
Posted by Michael Wonder on 16 Apr 2019
Labor to fast-track leukaemia drug trials
17 April 2019 - Patients with deadly blood cancers will get faster access to potentially life-saving drug trials if Labor ...
Posted by Michael Wonder on 10 Apr 2019
FDA, Brigham and Women’s to test if RWE is ripe now for replacing clinical drug trials
10 April 2019 - Can real-world evidence substitute for a clinical drug trial that meets the full gold standard on data? ...
Posted by Michael Wonder on 09 Apr 2019
Minimal residual disease as a surrogate outcome for product development for multiple myeloma: comparing FDA and EMA guidances
8 April 2019 - This article discusses the need to update regulatory science to include the use of minimal residual disease ...
Posted by Michael Wonder on 04 Apr 2019
The importance of predefined rules and pre-specified statistical analyses: do not abandon significance
4 April 2019 - For decades, statisticians and clinicians have debated the meaning of statistical and clinical significance. ...
Posted by Michael Wonder on 04 Apr 2019
FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy plans and to making sure they do not impede generic drug development
4 April 2019 - Today, the U.S. FDA issued guidance for industry, REMS: FDA’s Application of Statutory Factors in Determining When ...
Posted by Michael Wonder on 30 Mar 2019
Statement by FDA Commissioner, Director of FDA’s Center for Drug Evaluation and Research and Director of FDA’s Center for Biologics Evaluation and Research on expanded access–looking forward
29 March 2019 - For more than 30 years, the FDA has supported patients’ access to investigational medical products for ...
Posted by Michael Wonder on 28 Mar 2019
Drug makers continue to clamour for FDA approval of orphan drugs
28 March 2019 - Orphan drugs may serve small groups of patients, but they generate big numbers at the Food ...
Posted by Michael Wonder on 28 Mar 2019
Take over pharma to create new medicines, says top adviser
27 March 2019 - Part of the drugs industry should be taken over to make new antibiotics, an influential economist ...
Posted by Michael Wonder on 23 Mar 2019
FDA takes new steps to advance natural history studies for accelerating novel treatments for rare diseases
22 March 2019 - The U.S. FDA today issued the draft guidance, Rare Diseases: Natural History Studies for Drug Development. ...
Posted by Michael Wonder on 19 Mar 2019
FDA implements new policies to advance the development of drugs to treat or prevent HIV, including in paediatric patients, as part of efforts to end HIV infection
19 March 2019 - The U.S. FDA today issued two final guidances for industry to help product sponsors understand the ...
Posted by Michael Wonder on 14 Mar 2019
Statement by FDA Commissioner on new strategies to modernise clinical trials to advance precision medicine, patient protections and more efficient product development
14 March 2019 - Modernizing clinical trials is an agency wide priority. ...