Blog
RSS FeedPosted by Michael Wonder on 02 Oct 2017
Statement from FDA Commissioner Scott Gottlieb on the FDA’s adverse event reporting system and new search tool
2 October 2017 - The FDA’s adverse event reporting system is a database that contains adverse event reports, medication error reports ...
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 25 Sep 2017
Many drug companies fail to conduct timely safety checks on medicines after FDA approval
22 September 2017 - In the rush to approve new medicines, the U.S. FDA often requires drug companies to study ...
Posted by Michael Wonder on 24 Sep 2017
Generics industry calls FDA draft guidance on priority reviews 'basically inoperable'
22 September 2017 - A generic drug industry group and several companies have taken issue with recent US FDA draft ...
Posted by Michael Wonder on 23 Sep 2017
FDA clears biotech drug copycats, but buying them isn’t so easy
18 September 2017 - Basically, there’s a gazillion patents,’ says consultant. ...
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 12 Sep 2017
Why is the FDA chief so worried about pharma profits?
11 September 2017 - Developing new drugs is a costly business. So, too, is paying for the ever more expensive ...
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. ...
Posted by Michael Wonder on 03 Aug 2017
Addressing antimicrobial resistance and stewardship: the Priority Antimicrobial Value and Entry (PAVE) award
3 August 2017 - Antimicrobial-resistant infections affect more than 2 million people annually in the United States alone, accounting for an ...
Posted by Michael Wonder on 29 Jul 2017
Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?
26 July 2017 - Surrogate outcomes are not intrinsically beneficial to patients, but are designed to be easier and faster to ...
Posted by Michael Wonder on 24 Jul 2017
Companies rush to develop ‘utterly transformative’ gene therapies
23 July 2017 - The approval of gene therapy for leukaemia, expected in the next few months, will open the ...
Posted by Michael Wonder on 12 Jul 2017
FDA collaborates to promote safety, quality in clinical trials done in India
12 July 2017 - After more than 16 hours of travel, we touch down in Mumbai late in the evening ...