Search Results for Patient Groups

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How can FDA be Improved? Patient Groups Offer Ideas By Alexander Gaffney, RAC - Published 10 December 2014

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.

Categories: News, US, FDA

Tags: FDASIA, Patients, Patient Groups, Patient-Centered Drug Development, FDASIA Section 917, Recommendations for FDA

Is FDA Listening Enough to Patients? Agency Wants Feedback By Alexander Gaffney, RAC - Published 03 November 2014

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.

Categories: News, FDA, Drugs, Medical Devices

Tags: Patient-Focused Drug Development, Patients, Patient Groups, Patient Preference Initiative, FDASIA

As FDA Takes Notice of Patients, Groups Trying to Influence Regulatory Policy do as Well By Alexander Gaffney, RAC - Published 03 June 2014

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.

Categories: News, US, FDA

Tags: Patient Groups, Patient Involvement, FDASIA, FDASIA Section X, Patient-Focused Drug Development Initiative, FasterCures

Legislators Borrow From FDA's Approach in Seeking Patient Input About Regulatory Process By Alexander Gaffney, RAC - Published 19 May 2014

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.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, In vitro diagnostics, Medical Devices

Tags: 21st Century Cures Initiative, Energy and Commerce, Patient Groups, Patient Advocacy Groups, Legislators