Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 30 Oct 2017
A new team aims to slash drug development time — with help from the feds
27 October 2017 - A global pharma company is teaming up with federal research labs and academics in an ambitious ...
Posted by Michael Wonder on 16 Oct 2017
The cost of developing drugs is insane. That paper that says otherwise is insanely bad.
16 October 2017 - You probably know this poem, or at least the story it tells. One man likens the ...
Posted by Michael Wonder on 10 Oct 2017
A flawed study depicts drug companies as profiteers
9 October 2017 - Even the authors admit their selection criteria are a ‘critical limitation.’ That’s an understatement. ...
Posted by Michael Wonder on 02 Oct 2017
Reducing the hurdles for complex generic drug development
2 October 2017 - Earlier this year, I announced our Drug Competition Action Plan to advance new policies aimed at bringing ...
Posted by Michael Wonder on 27 Sep 2017
Making advances against Sickle cell disease
26 September 2017 - The medical definition of sickle cell disease – a group of inherited red blood cell disorders caused ...
Posted by Michael Wonder on 19 Sep 2017
Drug development at the portfolio level is important for policy, care decisions and human protections
19 September 2017 - The development of a new drug is often portrayed as a series of increasingly demanding clinical trials, ...
Posted by Michael Wonder on 14 Sep 2017
Tragedy, perseverance, and chance — the story of CAR-T therapy
13 September 2017 - In 2010, 5-year-old Emily Whitehead was diagnosed with acute lymphoblastic leukaemia. Though her parents were told that ...
Posted by Michael Wonder on 12 Sep 2017
FDA is advancing the goals of the Orphan Drug Act
12 September 2017 - Three months ago, I committed to fully eliminate a backlog of about 200 orphan drug designation requests ...
Posted by Michael Wonder on 13 Aug 2017
A cancer conundrum: too many drug trials, too few patients
12 August 2017 - With the arrival of two revolutionary treatment strategies, immunotherapy and personalised medicine, cancer researchers have found ...
Posted by Michael Wonder on 03 Aug 2017
A rush for immunotherapy cancer drugs means new bedfellows
3 August 2017 - Fierce rivals in pharma are co-operating. ...