NCATS Seeking Information on Opportunities and Challenges for Platform Vector Human Gene Therapy Trials in Rare Diseases
The National Center for Advancing Translational Sciences (NCATS) released a request for information soliciting input on the use of viral vectors as platforms for therapeutic gene delivery to specific organs or cell types, and how such platforms might be developed most efficiently in clinical trials for the treatment of multiple diseases.
Congress Changes Stance on ACA Repeal and Replace
On July 13, 2017, the U.S. Senate released an updated
version of the Better Care Reconciliation Act (BCRA), legislation to repeal
large provisions of the Affordable Care Act (ACA).
DEA Eliminates Grace Period for Registration Renewal
Through a notice on its website, the Drug Enforcement Administration (DEA) recently announced significant changes to its registration renewal process. Effective January 1, 2017, the DEA is eliminating the informal grace period which the agency has previously allowed for registrants to renew their registrations.
CMS Announces End to Medicare Part B Drug Payment Model
On December 15, 2016, the Centers for Medicare and Medicaid Services (CMS) announced the cancellation of Medicare Part B Drug Payment Model. CMS initially proposed the demonstration on March 8, 2016 to test new models in how physician-administered drugs are paid under the Medicare program.