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A Regulator Looks Back On What We Learned From Accelerated SARS-CoV-2 Neutralizing mAbs Development

Prior knowledge, platforms, parallel backup programs, and strategic timing all come into play when rapidly scaling up a mAbs development program in.

United statesMashonaland eastMaria teresa gutierrez lugoUniversity of arizonaAbs and those in developmentPublic health emergencyHealth servicesNational autonomous university of mexicoOffice of biotechnology productsDevelopment programDepartment of humanBiotechnology productsMonoclonal antibody productsHuman useThat leverage experience from licensedIndustry and regulators to collaborate

FDA Announces The Discontinuation Of Certain COVID-19-Related Guidance Documents - Operational Impacts and Strategy

In the wake of the Department of Health and Human Services' (HHS) February announcement that they will be discontinuing the COVID-19 public health emergency (PHE) declaration on May 11, 2023.

United statesCoagulation systems for measurement of viscoelastic propertiesHealth careGuidance documents expiring with the public healthExpiration of the public health emergencyDevelopment of monoclonal antibody productsHealth emergencyPublic health emergencyPublic health emergency guidanceEnforcement policy for digital health devicesHuman servicesDevelopment of abbreviated new drug applications duringDrug administrationParty certificationPublic health emergency guidance for industryPublic health

FDA approves use of monoclonal antibodies to treat animal diseases

This week, the U.S. Food and Drug Administration approved a new treatment for osteoarthritis in cats, marking the first time a monoclonal antibody drug has been FDA approved for treatment

Solensia to zoetis incDrug administrationMonoclonal antibodiesMonoclonal antibody productsFood and drug administrationSide effect

FDA approves use of monoclonal antibodies to treat animal diseases

This week, the U.S. Food and Drug Administration approved a new treatment for osteoarthritis in cats, marking the first time a monoclonal antibody drug has been FDA approved for treatment

Solensia to zoetis incDrug administrationMonoclonal antibodiesMonoclonal antibody productsFood and drug administrationSide effect

FDA approves use of monoclonal antibodies to treat animal diseases

This week, the U.S. Food and Drug Administration approved a new treatment for osteoarthritis in cats, marking the first time a monoclonal antibody drug has been FDA approved for treatment

Solensia to zoetis incDrug administrationMonoclonal antibodiesMonoclonal antibody productsFood and drug administrationSide effect

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