FDA has issued new guidance on cybersecurity information that medical device manufacturers are required to submit beginning this week as part of premarket submissions, but the agency says it won’t automatically reject marketing applications for the next six months as companies grapple with how to show their products are protected from cyberattacks.
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FDA Approves First OTC Naloxone Nasal Spray, Generics Must Now Switch
FDA on Wednesday (March 29) approved Emergent BioSolutions’ 4-milligram over-the-counter Narcan nasal spray -- the first-ever naloxone product to be made available OTC, meaning the medication, which is used to reverse the effects of opioid overdose, can be sold directly to consumers in drug stores, grocery stores, gas stations and online.
Latest Pandemic News
E&C GOP Demand More Info About FDA-Funded Gain-Of-Function Studies
Top House Energy & Commerce Committee Republicans are demanding more information from FDA on its funding and use of specific gain-of-function research methods, saying the agency provided an inadequate response to an earlier inquiry about its research on coronaviruses.
Devices Available Under EUA Can Stay On Market Pending FDA Review
FDA Will Loosen COVID LDT Regs When EUA Declaration Ends
FDA Details Plan To Phase Out COVID-Related Medical Device Policies
Latest News
HHS Secretary Xavier Becerra defended the administration’s plans for a nursing home minimum staffing ratio on Tuesday (March 28) as nursing home stakeholders anxiously await its release, which they believe will be included as part of the agency’s annual proposed pay rule for skilled nursing facilities.
Republican leaders on the House Energy & Commerce Committee are calling for FDA to provide them with more information about ongoing drug shortages, including how the agency is working to mitigate shortages using the information that drug makers are supposed to report about manufacturing and supply.
FDA advisers on May 9 will meet to discuss HRA Pharma’s application for the first-ever over-the-counter birth control pill in the United States, the agency announced Tuesday (March 28), five months after postponing discussions on the pill.
HHS Secretary Xavier Becerra told Sen. Sheldon Whitehouse (D-RI) he made a persuasive case for an end-of-life Medicare waiver package that would bundle nursing home, home health and palliative care waivers -- even though the request stalled at CMS’ innovation center through multiple administrations.
FDA signals in a new draft guidance that using the same clinical trial population for both accelerated and full approval applications and relying on surrogate endpoints data for both steps could become more common.
FDA on Friday (March 24) published draft guidance detailing how and when food manufacturers should include dietary guidance statements on packaged food products in a bid to encourage companies to promote good nutrition, provide greater consistency in labeling and help consumers make informed choices.
Health care entities made up the largest share of ransomware attack targets in 2022, according to an FBI report that underlines recent emphasis on the growth of cyberattacks against critical U.S. infrastructure.
Susan Mayne, who has led FDA’s food center since 2015, will step down from her role as center director on May 31, Mayne and FDA chief Robert Califf announced in a pair of emails send out to agency staff Monday (March 27), coming as FDA begins the process of restructuring its human foods program.
FDA Food Overhaul
Yiannas: FDA’s Food Overhaul Plan ‘Falls Short’ Of What Agency Needs
FDA Commissioner Robert Califf’s plan to appoint a deputy commissioner to oversee the agency’s soon-to-be-restructured food program “falls short,” as it fails to ensure that the person who holds the title has the authority they need to fully take charge of FDA’s food operations, Frank Yiannas, former FDA deputy commissioner for food policy and response, told Inside Health Policy Tuesday (March 28).
Yiannas: Congress Should Help Spur Competition In Infant Formula Market
MA Debate Intensifies
GOP Blasts Biden For ‘Mismanaging Medicare,’ But Becerra Cries Foul
Congressional Republicans are calling on CMS to provide a glut of information about its proposals included in the highly controversial Medicare Advantage advance notice, coming as legislators continue to squabble over what constitutes a cut to the Medicare program and how best to preserve the Medicare trust fund’s solvency.
Medicaid Unwinding
Lawmakers Push HHS For Quick Medicaid Unwinding Data Release
Nearly 65 lawmakers want CMS to publicly share state Medicaid unwinding data like the number of renewals initiated and call center volume at the end of every month as well as use the agency’s full enforcement authority, though the administration says data is only part of determining when a state is out of compliance and it likely won’t have a complete data set on redeterminations until May or June.
Tsai Appears Receptive To Calls To Slow Up Medicaid Enrollment Rule
Covering the hottest new health policy debate in Washington -- in-depth reporting on the surging efforts to tackle social, racial and economic barriers to equitable health care.
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