Blog
RSS FeedPosted by Michael Wonder on 16 Sep 2019
FDA seeks input on product-specific guidances to facilitate generic drug development
16 September 2019 - Today, FDA published 53 product-specific guidances (PSGs) – 34 new guidances and 19 revised guidances, including ...
Posted by Michael Wonder on 09 Sep 2019
Who’s missing from breast cancer trials? Men, says the FDA
9 September 2019 - Men do get breast cancer, but they account for fewer than 1 percent of patients and often ...
Posted by Michael Wonder on 28 Aug 2019
Promoting paediatric drug research and labelling — outcomes of legislation
28 August 2019 - Congress has modified regulations of the FDA to promote research assessing the efficacy and safety of drugs ...
Posted by Michael Wonder on 28 Aug 2019
FDA urges inclusion of men in breast cancer clinical trials
28 August 2019 - Men with breast cancer make up less than one percent of all breast cancer cases, but ...
Posted by Michael Wonder on 27 Aug 2019
Congress should be promoting, not discouraging, the development of biosimilars
27 August 2019 - Drug prices continue to dominate the headlines, yet many of the policy ideas being considered in ...
Posted by Michael Wonder on 26 Aug 2019
Developing real-world data and evidence to support regulatory decision-making
26 August 2019 - On 3 October, the FDA and the Duke-Margolis Center for Health Policy will hold a conference, ...
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26 August 2019 - The draft guidance, Male Breast Cancer: Developing Drugs for Treatment, includes draft recommendations for inclusion of males ...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 14 Aug 2019
Syapse announces research collaboration with the FDA focused on the regulatory use of real-world evidence
14 August 2019 - Collaboration will advance the derivation of real-world oncology endpoints and provide insights into the use of real-world ...
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FDA issues draft guidance regarding clinical trial design for newborns
31 July 2019 - Today, the U.S. Food and Drug Administration issued the draft guidance, General Clinical Pharmacology Considerations for Neonatal ...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 04 Aug 2019
Vas Narasimhan of Novartis: ‘we are not at all prepared for a pandemic’
1 August 2019 - The son of Indian immigrants read Greek philosophy and worked at McKinsey before joining a giant drug ...
Posted by Michael Wonder on 31 Jul 2019
Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies)
31 July 2019 - EMA and the US FDA have published today a report on their joint workshop with stakeholders ...
Posted by Michael Wonder on 29 Jul 2019
Harms from uninformative clinical trials
25 July 2019 - Individuals who enroll in clinical trials do so with the belief that their participation will help ...
Posted by Michael Wonder on 17 Jul 2019
Trump to order drive for improved flu vaccine
16 July 2019 - President Donald Trump is readying an executive order that would direct HHS to overhaul the development ...
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 ...