FDA Food and Drug Administration Patients Pharmaceutical products 
Pharmaceutical Technology
JUNE 1, 2023
The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. They are available in 2mg, 5mg and 10 mg dosages and are the generic equivalent of Swedish Orphan Biovitrum’s Orfadin.
European Pharmaceutical Review
APRIL 27, 2023
Solving this issue will improve industry best practice, increase public confidence and create a more efficient pathway to patients; but it necessitates enhanced collaboration between companies. The post What gene therapy manufacturers can gain from collaboration appeared first on European Pharmaceutical Review.
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European Pharmaceutical Review
AUGUST 23, 2022
FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The prevalence of fake drugs is a continually growing problem worldwide. 1 Simply, pharmaceutical products are the most vulnerable to counterfeiting. All protein?based
European Pharmaceutical Review
SEPTEMBER 29, 2022
The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.
Pharmaceutical Technology
DECEMBER 14, 2022
Harrow has signed a binding agreement to acquire exclusive US commercial rights to five ophthalmic products of Novartis. These products, namely, Ilevro, Vigamox, Maxidex, Nevanac and Triesence, have received approval from the Food and Drug Administration (FDA).
Pharma Marketing Network
AUGUST 9, 2023
The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.
European Pharmaceutical Review
OCTOBER 19, 2022
Patents are often described as the ‘lifeblood’ of pharmaceutical companies. 1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment.
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