Over the coming days, Inside Health Policy will roll out a series of articles based on conversations with key stakeholders regarding their impressions of Gottlieb’s progress thus far, and where they see him taking the agency on key issues, including: off-label promotion, regulatory reform and drug pricing.
FDA has significantly reworked portions of its guidelines relating to medical device manufacturers' sharing of patient-specific information with individual patients upon their request.
FDA announced Monday (Nov. 6) that the agency would exempt from premarket review all in vitro tests marketed to consumers for detecting genetic risk of developing a disease, so long as manufacturers have received a first-time FDA marketing authorization for their systems.
FDA is taking steps to modernize its organizational structure and improve coordination among its expert staff, as well as reconsidering its approach to risk-benefit assessment in pre- and postmarket drug reviews, especially in regards to opioids, FDA Commissioner Scott Gottlieb said at a National Press Club luncheon on Friday (Nov. 3).
As FDA rethinks some of its Risk Evaluation and Mitigation Strategies (REMS) requirements on opioid manufacturers, some attorneys, including a former FDA chief counsel, agree the agency could consider including a take-back program as part of the restrictions, despite what's seen as inevitable pushback from industry.
Endo Pharmaceuticals and subsidiary Par Sterile Products are suing FDA to block the agency's current interim policy on compounding of bulk substances by outsourcers, which they argue ignores congressional intent under the Drug Quality and Security Act (DQSA) and violates drug law by allowing copies of FDA-approved drugs to be compounded in bulk while bypassing the FDA approval process
Due to the failure of traditional clinical trials to predict the potential for opioid users to turn to illicit drugs, FDA under current law can and should more closely consider potential public health impacts in its decisions to approve and withdraw approval of drugs, especially in the opioid space, Patricia Zettler, former associate chief counsel for FDA and current associate professor of law at Georgia State University College of Law, argued during the Food and Drug Law Institute (FDLI) Symposium Friday (Oct. 20).
FDA unveiled Monday (Oct. 23) new educational materials for prescribers explaining the basics of biosimilars, including what the drugs are and how they are approved.
Approximately 50 critical medical devices are being monitored for risk of shortage due to Hurricanes Irma and Maria, FDA Commissioner Scott Gottlieb said Friday (Oct. 20).
FDA approved Wednesday (Oct. 18) Kite Pharma's Yescarta (axicabtagene ciloleucel), marking the second gene therapy approved in the United States and the first for certain types of non-Hodgkin lymphoma.
As the FDA continues to delay several food-related regulations, it appears that the agency is still committed to taking steps to evaluate how the agency regulates 'healthy' and other food claims.
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