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Explained | Why are Indian drugmakers under the lens?

Explained | Why are Indian drugmakers under the lens?
thehindu.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thehindu.com Daily Mail and Mail on Sunday newspapers.

Himachal pradeshSri lankaJammu and kashmirTamil naduShree agnihotriSumathi chandrashekaranDinesh thakurRiddhi jhaveriPrashant reddyMinistry of healthDrugs administrationDrug administrationNigeria national agency for foodHimachal pradesh drug control administrationCentral drugs standard control organisationMarion biotech

FDA: Only licensed professionals to give Pfizer bivalent vaccines once sold commercially

FDA: Only licensed professionals to give Pfizer bivalent vaccines once sold commercially
cnnphilippines.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from cnnphilippines.com Daily Mail and Mail on Sunday newspapers.

Metro manilaPhilippines generalSamuel zacateJesusa joyce cirunayDepartment of healthDrug administrationDrug regulationGeneral samuel zacate

Only licensed health workers can inject Pfizer bivalent jabs to be sold â€ FDA

Only licensed health workers can inject Pfizer bivalent jabs to be sold â€ FDA
philstar.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from philstar.com Daily Mail and Mail on Sunday newspapers.

Jesus joyce cirunayCristina chiSamuel zacateDrug administrationGeneral samuel zacateDrug regulation

Gambia tightens pharmaceutical quality checks for shipments from India

At least 70 children died in the West African country last year due to acute kidney injury, which the doctors had linked to adulterated cough syrups from India.

Rajeev singh raghuvanshiMarkieu janneh kairaWorld heath organizationWorld health organization good manufacturing practicesGambia medicines control agencyMaiden pharmaceuticalsWest africanPromethazine oral solutionKofexmalin baby cough syrupMakoff baby cough syrupMagripn cold syrupHaryana based maidenQuntrol laboratoriesClean reportWorld health organizationGood manufacturing practices

FDA s accelerated approval pathway for drugs is important but imperfect

During my years as a Food and Drug Administration official, I learned that the available data on a new drug are seldom as complete and unequivocal as you might like. But getting drugs to patients can be a matter of life or death, so you need to make hard decisions. Fortunately, the regulations offer some flexibility so that the criteria for demonstrating efficacy are more lenient in certain critical situations. One of those pathways is called “accelerated approval.”

United statesJournal of the american medical associationDrug administrationAmerican medical associationAccelerated approvalDrug regulationOmnibus spending bill