Blog
RSS FeedPosted by Michael Wonder on 28 Aug 2019
Placebos and blinding in randomised controlled cancer clinical trials for drug and biological products: guidance for industry
28 August 2019 - This guidance provides recommendations to industry about the use of placebos and blinding in randomised controlled clinical ...
Posted by Michael Wonder on 26 Aug 2019
FDA encourages inclusion of male patients in breast cancer clinical trials
26 August 2019 - The draft guidance, Male Breast Cancer: Developing Drugs for Treatment, includes draft recommendations for inclusion of males ...
Posted by Michael Wonder on 05 Aug 2019
FDA issues draft guidance regarding clinical trial design for newborns
31 July 2019 - Today, the U.S. Food and Drug Administration issued the draft guidance, General Clinical Pharmacology Considerations for Neonatal ...
Posted by Michael Wonder on 29 Jul 2019
FDA updates draft guidance on rare paediatric disease priority review voucher program
29 July 2019 - The U.S. FDA today issued a revised draft guidance, Rare Paediatric Disease Priority Review Vouchers – ...
Posted by Michael Wonder on 23 Jul 2019
FDA reinforces need for applicants to submit thorough and timely safety information for combination medical products
22 July 2019 - Today, the U.S. FDA released a final guidance, “Post-marketing Safety Reporting for Combination Products,” for applicants ...
Posted by Michael Wonder on 27 Jun 2019
FDA takes new step to help advance the transition of certain biological products
27 June 2019 - Today the U.S. FDA issued a proposed rule to amend its regulations on the use of master ...
Posted by Michael Wonder on 27 Jun 2019
FDA takes steps to spark development of heart failure drugs
27 June 2019 - The draft guidance, Treatment for Heart Failure: Endpoints for Drug Development, when finalised, will describe the agency’s ...
Posted by Michael Wonder on 04 Jun 2019
Consultation on draft guideline on quality requirements for medical devices in combination products
3 June 2019 - EMA has released a draft guideline on the quality requirements for medical devices in human medicines ...
Posted by Michael Wonder on 21 May 2019
FDA replaces withdrawn biosimilar guidance with new one on quality-related considerations
21 May 2019 - A week after finalizing guidance on developing interchangeable biosimilars, the US FDA has drafted guidance for ...
Posted by Michael Wonder on 21 May 2019
Framework for the regulation of regenerative medicine products
21 May 2019 - The U.S. FDA has published four final guidance documents that are part of a comprehensive policy framework ...
Posted by Michael Wonder on 13 May 2019
Considerations in demonstrating interchangeability with a reference product guidance for industry
9 May 2019 - This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable ...
Posted by Michael Wonder on 09 May 2019
FDA issues draft guidance to industry on submitting real-world evidence in new drug and biologic applications
8 May 2019 - Today, the U.S. FDA published the draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence ...
Posted by Michael Wonder on 02 May 2019
FDA advances the science of patient input by seeking specific feedback on patient preferences that may impact regulatory decisions on medical devices
2 May 2019 - The U.S. FDA today opened a docket to receive input from stakeholders on a new priority ...
Posted by Michael Wonder on 02 May 2019
FDA's efforts to advance the development of gene therapy
1 May 2019 - Gene therapy has been on the horizon for several decades and has now become a reality in ...
Posted by Michael Wonder on 20 Apr 2019
FDA's efforts to advance the development of biologics
17 April 2019 - The FDA’s Center for Biologics Evaluation and Research is working at the forefront of 21st century ...