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Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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Can I take Ozempic if I’m not diabetic?

The Checkup by Singlecare

Ozempic (semaglutide) is an injectable drug approved by the Food and Drug Administration (FDA) to treat Type 2 diabetes and reduce the risk of major cardiovascular events in people with Type 2 diabetes and known heart disease. Although GLP-1 drugs have been around since 2005, Ozempic was only made available in 2017.

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Patents: a necessary evil?

European Pharmaceutical Review

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. Letter to FDA, 06 July 2022.

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IoT innovation: Leading companies in nanoparticles for drug delivery

Pharmaceutical Technology

GlobalData’s analysis also uncovers the companies at the forefront of each innovation area and assesses the potential reach and impact of their patenting activity across different applications and geographies. Bristol-Myers Squibb is the leading patent filer in nanoparticles for drug delivery.

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A history of AstraZeneca

pharmaphorum

But although it was dubbed a “dangerous game”, some companies came out on top… On 6th April 1999, two companies with similar science-based cultures and a shared vision of the pharmaceutical industry came together to form what’s now considered as one of the top ten pharma companies in the world: AstraZeneca.

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An Annex 1 and Pharma 4.0 perspective on water quality

European Pharmaceutical Review

The US Food and Drug Administration (FDA) defines eight different types of water: non-potable, potable (drinkable), purified, water for injection (WFI), sterile water for injection, sterile water for inhalation, bacteriostatic water for injection and sterile water for irrigation. Chemometrics and Intelligent Laboratory Systems , 2005, Årg.