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. Source: GlobalData, Pharma Intelligence Center Drug Database (Accessed March 20, 2023). © GlobalData. ©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.
Pharma in Brief
AUGUST 9, 2021
On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. The following is a general summary of some of the highlights from the proposed amendments discussed in the Notice of Intent. Biologic Drugs.
pharmaphorum
JANUARY 17, 2022
The man who sent the price of lifesaving drug Daraprim (pyrimethamine) rocketing from $13.50 Until recently, Daraprim was the only drug available to treat the disease and has been the gold standard treatment for toxoplasmosis for decades. a tablet to $750 overnight has been ordered to repay $64.6m (£47m).
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.
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. In 2017, the global medicines supply was interrupted when Hurricane Maria hit Puerto Rico, home to more than 500 medical product facilities and producer of 10% of all drugs consumed in America.
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