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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

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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.

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.