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US FDA’s Patent ‘Concerns’ Include Thickets, Product Hopping, And Evergreening

 
• By Nielsen Hobbs

Senators press for sharing of FDA applications with PTO as Woodcock letter seeks collaboration on everything from PTAB to patent term extensions to ‘possible misuse of the patent system.’

With a report due to Congress in January, Orange Book patent issues may find their way into user fee reauthorization legislation next year. • Source: Nielsen Hobbs

The US Food and Drug Administration is seeking to work with the Patent and Trademark Office on a variety of hot-button issues, but it seems unclear how much impact the collaboration will have on the intellectual property landscape for the pharmaceutical industry.

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ICH Modernizes Stability Testing Guideline

 
• By Vibha Sharma

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.

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US CDC ACIP Puts GSK’s Penmenvy Even With Pfizer, Prepares For Infant MedQuadFi, Lyme Vaccines

 
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