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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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Hikma shares rally after US launch of Advair generic resumes

pharmaphorum

Advair lost US patent protection in 2010 and exclusivity on the Diskus inhaler went in 2016 – but it took until February 2019 for the FDA to approve a generic from Mylan, now part of Viatris. The amendment was required because of enhanced packaging controls to meet new industry standards adopted since the filing.

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Digital investment promises to accelerate the use of wearable sensor data in clinical trials

pharmaphorum

Garabedian and his team plan to support VivoSense, not just with their funding package but with their industry network and connectivity. “We In 2010, when we founded VivoSense, we developed a software platform for analysis of wearable sensor data and electronic patient-recorded outcomes (PRO) and patient diary information.

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Lansoprazole vs Omeprazole: differences and similarities

Druggist

Overall, both omeprazole and lansoprazole are similar in terms of side effect profile, efficacy, cost and have proven to have a very favourable safety profile (Ito & Jensen, 2010). 2010 Dec;12(6):448-57. Buy on Amazon Price incl. References: eMC (2020). SmPC: Omeprazole 20 mg Gastro-Resistant Capsules, Hard. Curr Gastroenterol Rep.

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Victoza generic availability, cost, and dosage

The Checkup by Singlecare

Food and Drug Administration (FDA) in 2010. Since 2010, Victoza has had more FDA approvals, including one in 2019, where it was approved for pediatric patients with type 2 diabetes. The most significant difference you will notice is the packaging and most importantly the price, said Dr. Turner.

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Methodology to Define a Pharma 4.0™ Roadmap

ISPE

The goal is to break down complex processes into easy-to-grasp packages, including data privacy and information technology (IT) security. 2010 (IEC 62264-1 Mod): Enterprise-Control System Integration − Part 1: Models and Terminology. 13 May 2010. In the fourth and last step, the defined work packages are executed.

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What is a dosette box? How to get one?

Druggist

Dosette box is composed of small sealable compartments, which hold tablets removed from blister packaging (original pack). Pharmacies have the right to refuse this service unless the patient qualifies under the Equality Act (2010) (known previously as the Disability Discrimination Act 1995).