STAT News
AUGUST 22, 2022
federal court ordered a unit of Wockhardt, one of the largest makers of generic drugs, to refrain from making allegedly adulterated medicines at a facility in Illinois. After a decade of manufacturing problems, a U.S. However, the U.S. Continue to STAT+ to read the full story…
Pharmaceutical Technology
APRIL 4, 2023
Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. US reliance on India for generic drugs could have supply chain security and quality implications for critical medicines. ©GlobalData.
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Pharmaceutical Technology
OCTOBER 28, 2022
To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.
pharmaphorum
AUGUST 24, 2020
She served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/OPQ/CDER, responsible for new, generic, and biologic drug product quality review and facility assessment. Key sessions include: • Evaluating the ongoing Complications of Personnel Derived Contaminations. in Biology and Ph.D.
pharmaphorum
JANUARY 17, 2022
The company was slammed for restricting distribution of its drug so generic drug manufacturers couldn’t conduct bioequivalence tests or access a key ingredient used in the drug’s production. Many people carry the illness but do not exhibit symptoms.
pharmaphorum
SEPTEMBER 9, 2022
Water-borne illnesses are also likely to become more common, as increased rain and storm surges contribute to flooding and contaminated run off. Rising global temperatures will, for example, enhance the spread of mosquito-borne diseases like malaria and Zika, increasing the need for effective vaccines. Vulnerability .
Pharma in Brief
AUGUST 9, 2021
Rolling submissions, which are currently in use for COVID-19 drugs, would be extended to other drugs, such as those which address significant new and emerging infectious diseases in Canada, or which treat, prevent, or diagnose serious or severely debilitating diseases or conditions. Biologic Drugs. Manufacturing Controls.
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