Blog
RSS FeedPosted by Michael Wonder on 17 Jan 2019
FDA updates guidance on development of rare disease therapies
17 January 2019 - The FDA has revised its draft guidance for developing rare disease treatments to include the use ...
Posted by Michael Wonder on 16 Jan 2019
Challenges of non-intention-to-treat analyses
15 January 2019 - Over the past 5 decades, the randomised clinical trial has become the gold standard for evaluation ...
Posted by Michael Wonder on 14 Jan 2019
Why pharmaceutical companies are on a shopping binge
14 January 2019 - With the cost of R&D so high, it may make sense to spend money on a competitor. ...
Posted by Michael Wonder on 19 Dec 2018
FDA advances new scientific framework to promote greater predictability, efficiency in oncology drug development
19 December 2018 - Today, the U.S. FDA issued guidance, Clinical Trial Endpoints for the Approval of Cancer Drugs and ...
Posted by Michael Wonder on 13 Dec 2018
Statement from FDA Commissioner and Director of FDA’s Center for Drug Evaluation and Research on efforts to modernise generic drug labels while maintaining the efficiency of generic development
13 December 2018 - Protecting patient safety is at the core of the FDA’s mission. All FDA-approved drugs have benefits and ...
Posted by Michael Wonder on 12 Dec 2018
FDA takes aim at pharma’s biosimilar-delaying tactics
12 December 2018 - Ever-rising cost of insulins also to be targeted. ...
Posted by Michael Wonder on 06 Dec 2018
Statement from FDA Commissioner on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics
6 December 2018 - The health care system is integrating more effective ways to leverage electronic tools to gather and use ...
Posted by Michael Wonder on 06 Dec 2018
FDA publishes post CRL guidance for generic companies
4 December 2018 - The US FDA has published final guidance for the generics industry on post-complete response letter meetings. ...
Posted by Michael Wonder on 30 Nov 2018
FDA announces pilot program with WHO to expedite review of HIV drug applications
30 November 2018 - The U.S. FDA today announced a plan to work with the WHO to pilot a process to ...
Posted 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 22 Oct 2018
Edge in U.S. cancer drug development spurred by regulatory and reimbursement policies
22 October 2018 - It is presumed that anticipated regulatory and reimbursement policies are important considerations in the research and development ...
Posted by Michael Wonder on 15 Oct 2018
Statement by FDA Commissioner on FDA’s new steps to modernise drug development, improve efficiency and promote innovation of targeted therapies
15 October 2018 - The FDA continues to advance new policies, modernise our programs and advance opportunities for developing more targeted ...
Posted by Michael Wonder on 28 Sep 2018
CDER conversation: complex innovative trial designs
25 September 2018 - Complex innovative trial designs – including the use of adaptive, Bayesian, and other novel statistical approaches ...
Posted by Michael Wonder on 26 Sep 2018
Chinese drug maker clarifies development strategy for bringing cancer drug to the U.S. market
26 September 2018 - It’s no secret that major biopharmaceutical companies have had designs on the China drug market as a ...
Posted by Michael Wonder on 25 Sep 2018
Cost of clinical trials for new drug FDA approval are fraction of total tab
24 September 2018 - Clinical trials that support FDA approvals of new drugs have a median cost of $19 million, ...