Tuesday, May 26, 2015
Congress now has a second chance to act on the Research for All Act, which would bring gender equality to essential aspects of medical research.
Transparency and disclosure of clinical trial information has been growing in importance. Providing previously confidential clinical study results for public consumption is a key step toward increasing trust between the public and the industry and encouraging information sharing that could lead to new products or therapeutic approaches.
The second draft of the proposed 21st Century Cures Act—which aims to accelerate the discovery, development and delivery of next-generation health products—includes a significant increase in NIH funding, expansion of an FDA patient-focused drug development initiative and removal of some drug exclusivity provisions.
The EMA has updated its rules on declarations of interests for scientific committee members and experts. The updates further strengthen EMA’s policy by restricting involvement of experts in the scientific assessment of medicines if they plan to take up a job in the pharmaceutical industry. The updates also include a revised guide on how to complete the agency’s declaration of interest form.
FDA draft guidance on premarket studies of implantable minimally invasive glaucoma surgical devices
The majority of clinical development plans submitted for scientific advice to the European Medicines Agency (EMA) prior to a marketing authorization application were found not suitable for future benefit-risk assessment. Companies that changed their clinical development plans in accordance with the recommendation from EMA were more likely to be granted a marketing authorization.
The White House has released a comprehensive plan that identifies critical actions to be taken by key Federal departments and agencies to combat the rise of antibiotic-resistant bacteria. The National Action Plan for Combating Antibiotic-Resistant Bacteria, which was developed by the interagency Task Force for Combating Antibiotic-Resistant Bacteria in response to Executive Order 13676: Combating Antibiotic-Resistant Bacteria, outlines steps for implementing the plan.