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A Milestone in Facilitating the Development of Safe and Effective Biosimilars

The 50th biosimilar approval milestone also reflects our strategic approach to biosimilars, as outlined in the FDA’s Biosimilars Action Plan.

Hilary marstonPatrizia cavazzoniSarah yimDrug administrationAssociation of accessible medicinesNew drug officeTherapeutic biologicsChief medical officerDrug evaluationBiologics price competitionInnovation actAccessible medicinesAction planBiosimilars action plan

FDA Roundup: April 26, 2024

FDA Roundup: April 26, 2024
bubblear.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from bubblear.com Daily Mail and Mail on Sunday newspapers.

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FDA and OHRP publish draft guidance on facilitating understanding in informed consent | Hogan Lovells

As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research.

Patrizia cavazzoniHogan lovellsHilary marstonResearch ourFederal policyHuman subjectsCommon ruleInstitutional reviewReview boardsCooperative researchMedical officer hilary marston

Top Biden Covid official Jha set to depart June 15

The long-planned departure comes weeks after HHS allowed the Covid-19 public health emergency to lapse on May 11.

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Lessons Learned from COVID-19 Are Informing Preparation for Future Public Health Emergencies

While the HHS public health emergency is ending, COVID-19 remains a high priority and the U.S. Food and Drug Administration will remain engaged with numerous activities to protect and promote public health.

United statesRobertm califfHilary marstonDrug administrationPublic health emergencyPublic health servicePublic health emergency preparednessUs department of healthResponse missionDrug development for longHuman servicesGlobal health securityAdministration national biodefense strategyChief medical officerPublic health service actEmergency use authorizations

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