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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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Evaluating NMR relaxometry for antibody identification

European Pharmaceutical Review

Gregory’s industrial career spans an employment history with several major pharmaceutical companies. IPQ International Pharmaceutical Quality. 2007; 66(11-12): 963–8. 2007; 848(1): 79–87. 2007; 87(12): 2207–16. Cited 2023Feb]. Available from: [link] Egelhofer V, Gobom J, Seitz H, et al. Chromatographia.

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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.

Vaccines 113
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Top 20 Drugs with US Patent Expiry in 2023 Based on Total Sales Value

PharmaShots

Shots: Drug patent expiry is when a patent granted to a pharmaceutical company for a particular drug expires, allowing other companies to produce and sell generic versions Like every other utility patent, pharmaceuticals also get market exclusivity of 20 years. The exact mechanism of action is uncertain.

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Drug development and working with specialised Rare Disease networks

pharmaphorum

However, despite the work still left to be done, there are now a growing number of treatments in the pipeline and 2020 proved to be a remarkable year for orphan drug approvals, with the US FDA approving more orphan designated treatments than non-orphan drugs.

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Nine for 2023, part two: healthcare’s hard problem, the prognosis for diagnosis, and key new pharmacotherapy platforms

pharmaphorum

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. Innovation will power the market. A new hope: new pharmacotherapeutic platforms become commercially viable.

FDA 90
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Interview: Dr Alan S Louie – US Food and Drug Administration Delays

Pharmaceutical Technology

Nicola Boyes: The FDA has come under criticism recently for extreme delays in approving new drugs for the market, is the criticism valid and if so how are the delays impacting on the US pharmaceutical industry at present? In terms of concerns over safety, it has meant that the FDA has been essentially very cautious in moving forward.