STAT
JUNE 22, 2023
At a hearing Thursday, lawmakers in both parties talked about overhauling a 2015 law that aimed to shift physicians toward so-called value based payment models, rather than the traditional fee-for-service system. Congress is taking early steps towards changing the way Medicare pays physicians.
pharmaphorum
DECEMBER 22, 2022
Four Japanese drugmakers – Astellas, Eisai, Daiichi Sankyo, and Takeda – have joined forces in a partnership intended to reduce the environmental impact of pharmaceutical packaging. The post Japanese drugmakers make greener packaging pledge appeared first on.
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RX Note
MARCH 31, 2023
Limitations Child-resistant packaging can present difficulties for some aged individuals or people with disabilities. External Links Perceptions and Attitudes of People with Disabilities and Older Adults about Child-resistant Drug Packaging, 2012 Are child safety caps enough to keep kids out?, How Child Proof Caps Work?
LifeProNow
APRIL 6, 2023
As part of the comprehensive submission package to the European Marketing Authorization, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50 mg/mL 2 with the 100 mg/mL (HCF). In 2015, the EMA and US FDA approved Humira ® HCF, which contains adalimumab at a concentration of 100 mg/mL.”
European Pharmaceutical Review
JULY 25, 2022
These may be mislabelled or produced in fake packaging and, most dangerously, there is no regulation around their manufacture. According to the latest WHO estimates in 2015, this duped consumer base accounts for 50 percent of all online drug purchases. Supply-chain visibility.
European Pharmaceutical Review
JANUARY 30, 2023
As part of the submission package to the EMA, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50mg/ml with the 100mg/ml (HCF). In 2015, the EMA and US Food and Drug Administration (FDA) approved Humira ® HCF, which contains adalimumab at a concentration of 100mg/ml.
European Pharmaceutical Review
AUGUST 23, 2022
However, the researchers noted that a larger number of warning letters were issued to pharmaceutical manufacturers (ie, by CDER) than to medical device manufacturers (by CDRH) between 2015 and 2020. The major reasons for this were poor cGMP compliance and misbranding.
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