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, in its bid to tap real-world evidence to speed approvals of new drugs, is holding discussions with CMS to carve out each agency’s jurisdiction, FDA Principal Deputy Commissioner Amy Abernethy said.
Sen. Elizabeth Warren (D-MA), a contender for the 2020 Democratic presidential nomination, is calling on former FDA Commissioner Scott Gottlieb to step down from his recently announced board of directors position with the pharmaceutical giant Pfizer.
In draft guidance released Thursday (June 27), FDA clarifies that it wants to stimulate development of drugs that treat heart failure, even if the drugs only help improve patients’ physical function and lifestyle, but do not improve patients’ overall survival rates or decrease hospitalization rates.
Former FDA Commissioner Scott Gottlieb is joining the board of directors of Pfizer, which under Gottlieb’s leadership FDA accused of gaming drug patents to impede generic competition.
In a bid to avoid disruptions and potential shortages as biologic products transition from being regulated as drugs to being licensed as biologics, FDA issued a proposed rule Thursday (June 27) that would let those products continue to include certain information, by reference, in drug master files even after they complete their transition.
The House passed a minibus funding package on Tuesday (June 25) that aims to give FDA a $184 million funding boost over fiscal 2019 levels and redirect $100,000 from the agency’s general purpose funding towards its efforts to establish a safe, lawful level of cannabidiol (CBD) to be allowed in food and dietary supplements.
President Donald Trump on Monday (June 24) signed legislation that reups critical hazard preparedness programs at HHS. Stakeholders applauded the signing of the bill, which has been in limbo for months as several HHS pandemic preparedness authorities expired last year when the Senate failed to pass the legislation before the 115th session of Congress came to a close.
After several dozen sprout-related foodborne illness outbreaks, FDA warned sprout seed handlers at all levels of the supply chain to clean up their act by issuing draft guidance Monday (June 24) on how to reduce the risk of pathogen exposure during the production of sprout seeds.
The Supreme Court sided with plaintiffs in a Freedom of Information Act (FOIA) case that consumer advocacy groups had warned could have wide-ranging consequences for those that want to obtain information from the government, as it could tighten restrictions on what information can be released and virtually dry up data the groups have obtained from agencies such as FDA.
FDA on Friday (June 21) formally scrapped its hidden database of safety incidents associated with certain medical devices and said it will beef up its public reporting program instead.
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