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The Issue with Reissue: PTE Edition

The FDA Law Blog

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. FDA has already been there , of course, with respect to 180-day exclusivity.)

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STAT+: ‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices

STAT

But like any pharmaceutical company with an eye toward the future, Celgene continued to seek other ways to wring profits from its development work. Not long after the patent was awarded, the company leveraged federally funded research and began investigating different forms of the compound, called Revlimid.

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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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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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How to get acquisition ready – a seller’s guide to merger and acquisition in pharma

pharmaphorum

So, how do smaller pharmaceutical companies at the cutting edge get ready for their acquisition milestone, so they maximise their value and attractiveness? Any purchasing company would ideally like to integrate their acquisitions into their company seamlessly. She joined NSF in 2017.

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Re-envisioning mental health treatment using clinical VR

pharmaphorum

Clinical research in VR as a treatment for PTSD was accelerated in 2004 when an epidemiological study of PTSD was published , noting the rise in cases among veterans of the conflicts in Iraq and Afghanistan. Skip says this paper was a “call to arms” to find improved treatment methods.

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Primate models in pharma: What the future holds

Pharmaceutical Technology

However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004. The FDA’s Modernization Act 2.0