Blog
RSS FeedPosted by Michael Wonder on 06 Nov 2018
No matter what the FDA decides, new diabetes drugs will still require CV outcomes trials
6 November 2018 - At one time, Avandia (generic name: rosiglitazone) was a major diabetes drug for GSK with sales exceeding ...
Posted by Michael Wonder on 18 Oct 2018
Advancing toward the goal of global approval for generic drugs: FDA proposes critical first steps to harmonise the global scientific and technical standards for generic drugs
18 October 2018 - Too many Americans struggle with the high cost of drugs. In some cases, patients go without ...
Posted by Michael Wonder on 16 Oct 2018
FDA guides on minimal residual disease endpoint in haematologic cancer trials
16 October 2018 - FDA Commissioner Scott Gottlieb highlighted minimal residual disease's potential as a surrogate endpoint in clinical trials ...
Posted by Michael Wonder on 13 Sep 2018
FDA issues 54 product-specific guidances to promote generic drug access and drug price competition
13 September 2018 - The U.S. FDA today announced a new set of product-specific guidances to support industry in identifying ...
Posted by Michael Wonder on 22 Aug 2018
Statement by FDA Commissioner on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics
22 August 2018 - As we all work to confront the staggering human and economic toll created by the opioid crisis, ...
Posted by Michael Wonder on 04 Aug 2018
Statement from FDA Commissioner Scott Gottlieb on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes
3 August 2018 - As a public health agency, there is no greater impact we can have to improve the ...
Posted by Michael Wonder on 25 Jul 2018
Scientist invented a new pathway to approve biosimilars, and the FDA is listening
25 July 2018 - In an extraordinary move, the FDA has withdrawn the draft guidance, "Statistical Approaches to Evaluate Analytical Similarity,” ...
Posted by Michael Wonder on 20 Jul 2018
Statement from FDA Commissioner on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse
20 July 2018 - One of the ways that the U.S. FDA is working to address the opioid epidemic is ...
Posted by Michael Wonder on 20 Jul 2018
FDA provides scientific and regulatory clarity for generic drug developers through the issuance of 43 new or revised product-specific guidance documents, including hard-to-copy complex generics and abuse-deterrent formulations of opioids
20 July 2018 - The U.S. FDA today announced a new batch of product-specific guidances to support industry in identifying ...
Posted by Michael Wonder on 11 Jul 2018
Statement from FDA Commissioner on agency’s efforts to advance development of gene therapies
11 July 2018 - Once just a theory, gene therapies are now a therapeutic reality for some patients. ...
Posted by Michael Wonder on 25 Jun 2018
Statement by FDA Commissioner on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components
25 June 2018 - Over the past decade, we’ve seen a growing interest in the development of therapies derived from marijuana ...
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 12 Jun 2018
Statement from FDA Commissioner on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections
12 June 2018 - The increase in serious antimicrobial drug resistant infections is a critical public health concern and a ...
Posted by Michael Wonder on 12 Jun 2018
Statement from FDA Commissioner on new efforts to advance medical product communications to support drug competition and value-based health care
12 June 2018 - We’re living in a time of unparalleled scientific advancement. Innovative medical treatments continue to be developed ...
Posted by Michael Wonder on 06 Jun 2018
FDA’s new efforts to advance biotechnology innovation
6 June 2018 - Scientific advances in biotechnology, such as genome editing and synthetic biology, hold enormous potential to improve human ...