Tag Archives: FDA safety and innovation act

Patients on the Picket Line

By Ben Comer | Published: February 5, 2013

Good science can’t be rushed, even when the lives of patients hang in the balance. But regulatory science, and its relationship to a drug’s commercial success or failure, can inadvertently block access to individual patients in their hour of need.

Posted in Biotech, FDA, Legal, Market Access, Regulatory, Safety, healthcare | Also tagged Abigail Alliance, breakthrough therapies, Breast cancer, Cancer, compassionate use, Expanded Access Programs, FDA, HHS, Market Access, patient advocates, PDUFA V, policy | Leave a comment

Budget policies jeopardize FDA funding, user fees

By Guest Blogger | Published: September 25, 2012

Budget policies jeopardize FDA funding, user fees Even though Congress authorized both existing and new user fees for the Food and Drug Administration several months ago through the FDA Safety & Innovation Act (FDASIA), efforts to cut the federal deficit raises questions about how those fees will be collected and used in the coming year. FDA, [...]

Posted in FDA, Guest Blog, Regulatory | Also tagged CR, FDA, GDUFA, Medicare, Regulatory, Washington | Leave a comment

FDA User Fee Legislation Heads Toward Finish Line

By Jill Wechsler | Published: June 1, 2012

Legislation to reauthorize Food and Drug Administration user fee programs sailed through the House and Senate last month, setting the stage for leading legislators to resolve their differences and agree on a compromise measure. Much of the work will be tackled by Committee staffers who have been laboring over the legislative details for months. The [...]

Posted in Agency Insight, FDA, Regulatory | Also tagged FDA, FDA reform act, user fee programs | Leave a comment