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FDA Approves Many New Drugs in 2023 that Will Benefit Patients and Consumers

FDA’s Center for Drug Evaluation and Research (CDER) approved a wide range of therapies in 2023 that will help patients and consumers live better and possibly longer lives.

Patrizia cavazzoniDrug researchDrug administration centerPublic health emergencyDrug administrationDrug evaluationFor many typesNew drug therapy approvalsRare diseasesBringing therapiesFee goal performancePrescription drug user fee actPublic healthCycle approvalsSerious conditionsFast track

Claims, Lab, and EHR Data Can Make or Break a Drug Launch

Real-world data can help resolve access barriers by providing a highly detailed view into the barriers that impact specific patient populations.

United statesDinesh kabaleeswaranFront public healthUniversity of pennsylvaniaDrug evaluationAccess barriersSuccessful commercializationDrug therapy approvals

Eleven Potentially Practice-Changing Drugs Were Approved by the FDA in 2023

These drugs have interesting mechanisms, unique use, or may support expanded indications in the future.

United statesTreasure islandVonoprazan voqueznaZuranolone zurzuvaeDaprodustat jesduvroqGepirone exuaaTarsus pharmaceuticalsNational library of medicineSaturni study groupCenters for diseaseNational centerBausch health companiesFabre kramer pharmaceuticals announcesPhathom pharmaceuticalsMission pharmacal companyFabre kramer pharmaceuticals inc

Drug Name Confusion: List of Problem Medications Grows

The Institute for Safe Medication Practices, which is focused on preventing medication errors, added 82 new drug pairs to its list of medicines requiring special safeguards to reduce error risk.

United statesNew yorkLetairis ambrisentanZolpidem ambienMary ann kliethermesCitalopram celexaDrug administrationDrug safety instituteNew york timesInstitute for safe medication practicesMedication safety best practices for community pharmacyJournal of the american pharmacists associationBrand institute in miamiAmerican society of healthHealthcare providers service organizationSafe medication practices

Keeping pace

Environmental risk, biosafety and other key regulatory considerations  for cell and gene therapy trials - Magazine Article - PharmaTimes

United kingdomExceptional technologyGene therapy advisory committeeVaccines expert advisory groupEuropean parliamentGene therapy modification safety committeeInstitutional biosafety committeeDrug administrationAdvisory committeeRegulatory agencyResearch advisory committee nexCommission declarationEuropean unionEuropean medicines agencyCommittee of advanced therapiesCouncil directive

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