Blog
RSS FeedPosted by Michael Wonder on 16 Jan 2018
FDA Commissioner on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs
16 January 2018 - Scientific progress and new drug innovation don’t take place in a vacuum. ...
Posted by Michael Wonder on 07 Jan 2018
Medical research? Congress cheers. Medical care? Congress brawls.
6 January 2018 - They cannot agree on subsidies for low-income people under the Affordable Care Act or even how ...
Posted by Michael Wonder on 05 Jan 2018
Made in China: new and potentially lifesaving drugs
3 January 2018 - One new drug promises to stop cancer from spreading to other organs. Another would treat blood ...
Posted by Michael Wonder on 19 Dec 2017
Guidelines for statistical analysis plans
19 December 2017 - The emergence of the randomised clinical trial as the gold standard for the evaluation of new clinical ...
Posted by Michael Wonder on 19 Dec 2017
Republican bill to reduce tax credits for rare disease drugs
18 December 2017 - The target comes as a surprise under a Republican administration that has shown little interest in addressing ...
Posted by Michael Wonder on 15 Dec 2017
Statement from FDA Commissioner on new FDA efforts to support more efficient development of targeted therapies
15 December 2017 - In recent years, the medical community has experienced a shift in the way health care is ...
Posted by Michael Wonder on 14 Dec 2017
Bumper crop of new drugs fails to lift big pharma R&D returns
14 December 2017 - It is shaping up to be a bumper year for drug approvals, with U.S. officials clearing twice ...
Posted by Michael Wonder on 07 Dec 2017
FDA required studies of approved drugs make a big difference for public health
7 December 2017 - Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be ...
Posted by Michael Wonder on 07 Dec 2017
Speed, safety, and industry funding - from PDUFA I to PDUFA VI
7 December 2017 - The FDA Reauthorization Act of 2017 includes the sixth version of the Prescription Drug User Fee Act. ...
Posted by Michael Wonder on 05 Dec 2017
The FDA’s expedited programs and clinical development times for novel therapeutics, 2012-2016
5 December 2017 - The US FDA has 4 expedited programs to speed the development and review of drugs treating serious ...
Posted by Michael Wonder on 04 Dec 2017
Encouraging new uses for old drugs
4 December 2017 - US FDA approval of a new drug typically coincides with a period of patent protection, during which ...
Posted by Michael Wonder on 30 Nov 2017
Advancing medicinal nicotine replacement therapies as new drugs – a new step in FDA’s comprehensive approach to tobacco and nicotine
29 November 2017 - As the leading cause of preventable disease and death in the United States, tobacco causes more than ...
Posted by Michael Wonder on 28 Nov 2017
FDA issues guidance that could make it easier for EpiPen rivals to come to market
28 November 2017 - FDA issued guidance that says generic copies with some design differences may be approved as substitutable products. ...
Posted by Michael Wonder on 16 Nov 2017
Statement from FDA Commissioner on FDA’s comprehensive new policy approach to facilitating the development of innovative regenerative medicine products to improve human health
16 November 2017 - One of the most promising fields of science is the area of cell-based therapies and their ...
Posted by Michael Wonder on 16 Nov 2017
FDA announces comprehensive regenerative medicine policy framework
16 November 2017 - Framework aims to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy. ...