The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) recently issued two revised documents for its Manual of Policies and Procedures (MAPP): one addresses updated procedures for its data standards program and the other covers operational procedures for scientific interest groups (SIG).   The 10-page MAPP on data standards governance discusses the operating model to support the implementation of CDER’s data standards program. It r...

More than a dozen patient groups and trade associations are offering their advice to the US Food and Drug Administration (FDA) on ways the agency can improve its regulatory and administrative processes to take into account the views and expertise of patients and their advocates. Background Since 2012, FDA has launched several initiatives meant to better take into account the views of patients. Some, like its patient-focused drug development initiative , have involv...

When Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in 2012, its patient-centered provisions were among the biggest changes set to impact the culture of the US Food and Drug Administration (FDA). Now, two years later and with major planning already underway regarding the future of FDA's patient-centered activities, agency regulators are reaching out to the public to ask what more they can do to improve their efforts. Backgr...

An advocacy group focused on accelerating the discovery and approval of new therapies—and in particular therapies for under-served and rare diseases—has launched a new effort aimed at helping to bring patient perspectives into the regulatory process. Background In recent years, regulators and regulatory-minded groups alike have pressed to increase the involvement of patients in the regulatory process. The thinking is that patients are the best stakeholders to ask a...

House legislators are quickly moving ahead with a new plan that hopes to overhaul how the US regulatory system reviews new medical products, and are now soliciting input from a group that has not traditionally been at the center of the regulatory process: patient advocacy groups. Background In late April 2014, Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) announced the launch of a new initiative called the " 21st Century Cures Initiative ," which they said would be a...

The US Food and Drug Administration is announcing its intent to hold a meeting on how best to involve patients, patient advocacy groups and health professional groups in regulatory decision-making. The meeting, FDA's first Patient Network program Annual Meeting entitled "Input into FDA Benefit-Risk decision-making: Opportunities and Challenges," is being hosted by FDA's Office of Special Health Issues and will be held on 18 May 2012. FDA said in a statement, "the meetin...