Blog
RSS FeedPosted 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FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies
21 June 2018 - Today, the agency withdrew the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September ...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 20 Jun 2018
Budget matters: infrastructure to support robust generic drug competition
18 June 2018 - The FDA launched its Drug Competition Action Plan more than a year ago, with the aim of ...
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 12 Jun 2018
Statement from FDA Commissioner on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making
12 June 2018 - Over the past decade, advances in our understanding of the basic biology of serious and life-threatening ...
Posted by Michael Wonder on 09 Jun 2018
Clinical trial design and dissemination: comprehensive analysis of clinicaltrials.gov and PubMed data since 2005
6 June 2018 - Well conducted clinical trials are widely regarded as the best source of evidence on the efficacy and ...
Posted by Michael Wonder on 05 Jun 2018
FDA proposes process modernisation to support new drug development
4 June 2018 - The staff of the FDA’s Center for Drug Evaluation and Research (CDER) always tries to utilise cutting-edge ...
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
Multiplicity considerations in clinical trials
31 May 2018 - Making multiple comparisons increases the likelihood that a chance association could be interpreted as causal. ...
Posted by Michael Wonder on 30 May 2018
As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion
30 May 2018 - Agency will work closely with selected applicants to accelerate product development. ...
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
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 27 Apr 2018
FDA moves to encourage A.I. in medicine, drug development
26 April 2018 - It is establishing a new incubator focused on health technology. ...