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ICH Generic Drug Harmonization May Be Another Cost-Lowering Opportunity

 
• By Derrick Gingery

The international group will work on harmonizing scientific and technical standards for generic drugs, which could reduce duplication and development costs.

businessman and businesswoman are shaking hands and exchanging folder after agreement was reached

The US FDA may be able to use the International Conference on Harmonization to align generic drug standards around the world and by extension potentially lower development and patient costs.

ICH, which comprises representatives of many international regulators and is focused on creating common drug development standards, wants to move...

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No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
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The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 
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Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
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Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

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• By Dean Rudge

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European Industry Calls For Support As It Juggles Multiple Challenges

 
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At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.