Blog
RSS FeedPosted by Michael Wonder on 04 Apr 2019
FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy plans and to making sure they do not impede generic drug development
4 April 2019 - Today, the U.S. FDA issued guidance for industry, REMS: FDA’s Application of Statutory Factors in Determining When ...
Posted by Michael Wonder on 23 Mar 2019
FDA takes new steps to advance natural history studies for accelerating novel treatments for rare diseases
22 March 2019 - The U.S. FDA today issued the draft guidance, Rare Diseases: Natural History Studies for Drug Development. ...
Posted by Michael Wonder on 19 Mar 2019
FDA implements new policies to advance the development of drugs to treat or prevent HIV, including in paediatric patients, as part of efforts to end HIV infection
19 March 2019 - The U.S. FDA today issued two final guidances for industry to help product sponsors understand the ...
Posted by Michael Wonder on 05 Mar 2019
FDA is working to bridge gaps and meet needs for rare disease product development
28 February 2019 - There are approximately 7,000 rare diseases affecting an estimated 30 million people in the United States. ...
Posted by Michael Wonder on 15 Feb 2019
FDA advances new efforts to promote development of safe and effective regenerative medicine products
15 February 2019 - Today, the FDA finalised two guidance documents regarding regenerative medicine therapies. ...
Posted by Michael Wonder on 13 Feb 2019
Statement from FDA Commissioner on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs
13 February 2019 - Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. ...
Posted 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17 January 2019 - The FDA has revised its draft guidance for developing rare disease treatments to include the use ...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 15 Jan 2019
Statement from FDA Commissioner and Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies
15 January 2019 - The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced ...
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 18 Dec 2018
Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on new steps to promote innovations in medical devices that help advance patient safety
18 December 2018 - Spurring innovation of medical products so that patients can have access to safe, effective treatments that ...
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 11 Dec 2018
Statement from FDA Commissioner on new actions advancing the agency’s biosimilars policy framework
11 December 2018 - Our public health obligations touch on many aspects of how medical products are developed and used ...
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
Statement from FDA Commissioner on the FDA’s new effort for developing and class labelling of in vitro companion diagnostics for classes of oncology therapeutic products
6 December 2018 - One challenge we face right now, when it comes to developing diagnostics that can help target ...
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. ...