Blog
RSS FeedPosted 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 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
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 24 Oct 2017
Medical device development tools: helping to speed medical device evaluation and approval
24 October 2017 - The FDA relies on sound science in its decision-making, which provides medical device innovators with a ...
Posted by Michael Wonder on 24 Oct 2017
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies
24 October 2017 - Enabling patients and providers to have efficient access to new and innovative medical products that meet ...
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
The lifecycle of a rare disease cancer drug
10 October 2017 - One pharma company’s medicine illustrates how firms can benefit from different layers of market-exclusivity protections. ...
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 07 Oct 2017
FDA awards 15 grants for clinical trials to stimulate product development for rare diseases
6 October 2017 - The U.S. FDA today announced that it has awarded 15 new clinical trial research grants totalling ...
Posted 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 ...