Blog
RSS FeedPosted by Michael Wonder on 28 Jun 2018
The biopharmaceutical industry provides 75% of the FDA's drug review budget. Is this a problem?
28 June 2018 - Caroline Chen of ProPublica has written a provocative article challenging the objectivity of the FDA in its ...
Posted by Michael Wonder on 28 Jun 2018
Bias, operational bias, and generalisability in Phase II/III trials
27 June 2018 - Adaptive clinical trial designs improve the efficiency of the drug development process by allowing treatment decisions to ...
Posted by Michael Wonder on 25 Jun 2018
As the drug industry eyes the burgeoning biosimilar market, its united front is starting to crack
25 June 2018 - The pharmaceutical industry’s massive lobbying operation has a well-earned reputation for maintaining a united front on ...
Posted by Michael Wonder on 22 Jun 2018
FDA announces program to enhance early communications with biological product developers
22 June 2018 - The FDA’s new INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) meeting program was created ...
Posted by Michael Wonder on 21 Jun 2018
FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies
21 June 2018 - Today, the agency withdrew the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September ...
Posted by Michael Wonder on 05 Jun 2018
Embracing competition to empower biosimilars
5 June 2018 - In 2017, there were 46 new novel drug innovations, including new treatments for cancers, Parkinson’s disease, ...
Posted by Michael Wonder on 05 Jun 2018
FDA drafts new guidance on formal meetings between FDA, biosimilar sponsors
4 June 2018 - The US FDA has released new draft guidance on formal meetings between biosimilar sponsors and the ...
Posted by Michael Wonder on 04 Jun 2018
FDA wants to shorten new drug monopolies to cut costs
4 June 2018 - In an effort to increase competition and bring down prescription drug prices, FDA Commissioner Dr. Scott Gottlieb ...
Posted by Michael Wonder on 30 May 2018
Are big clinical trials relevant? Researchers disagree
29 May 2018 - Amid health care tailored to an individual’s DNA, do massive clinical trials that take years and involve ...
Posted by Michael Wonder on 17 May 2018
Statement from FDA Commissioner on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition
17 May 2018 - No patients should be priced out of medicines they need to support their health. ...
Posted by Michael Wonder on 17 May 2018
Addressing generic drug market failures - the case for establishing a non-profit manufacturer
17 May 2018 - Robust competition usually keeps the price of generic drugs well below that of brand-name drugs. When ...
Posted by Michael Wonder on 15 May 2018
FDA to name companies accused of hindering generic drug development
14 May 2018 - On Thursday, the FDA plans to start publishing the names of pharmaceutical companies that have been ...
Posted by Michael Wonder on 05 May 2018
Gottlieb pushes back against criticism of ‘breakthrough’ designation
4 May 2018 - FDA Commissioner Scott Gottlieb defended his agency’s “breakthrough therapy” program, which speeds review of drugs that ...
Posted by Michael Wonder on 28 Feb 2018
Drug makers lobby for antibiotic incentives in pandemic preparedness bill
27 February 2018 - A big legislative package due for renewal later this year could include hundreds of millions of ...
Posted by Michael Wonder on 13 Feb 2018
Statement from FDA Commissioner Scott Gottlieb on Administration’s request for new FDA funding to promote innovation and broaden patient access through competition
13 February 2018 - Additional resources will help advance initiatives to support novel medical technology and public health priorities such as ...