Monday, December 15, 2014
U.S. Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) have introduced a bill to create a new drug approval pathway to streamline access and encourage innovation and development of potentially lifesaving antibiotic drugs for patients, particularly Veterans who have encountered antibiotic-resistant bacteria while overseas.
Parent Project Muscular Dystrophy (PPMD), an advocacy organization working to end Duchenne muscular dystrophy, is urging Congress to build upon gains in recent years to further strengthen and enhance programs to ensure the patient voice is heeded during the drug development process. PPMD is advocating for provisions within the 21st Century Cures Initiatives focused on measuring how the agency is or is not using new patient engagement tools.
The Securities and Exchange Commission has suspended trading in four companies that claim to be developing products or services in response to the Ebola outbreak, citing a lack of publicly available information about the companies’ operations.
Peter Dutton, MP, Minister for Health for Australia, and the Jonathan Coleman, Minister of Health for New Zealand, have announced their governments’ agreement to cease efforts to establish a joint therapeutic products regulator, the Australia New Zealand Therapeutic Products Agency (ANZTPA).
The EMA has published its revised policy on handling declarations of interests for scientific committee members and experts. The revisions reflect a more balanced approach to handling conflicts of interests that aims to effectively restrict the involvement of experts with possible conflicts of interests in the agency’s work, while maintaining EMA’s ability to access the best available expertise.