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Generic Combination Products May Be Permitted Delivery Device Variations

 
• By Derrick Gingery

But US FDA officials say brand vs. generic product differences won't be appropriate in all cases and patient misuse remains a concern.

Machinery cogwheels, industry concept

US FDA officials seem open to some delivery device differences to make it easier for generic combination products to reach the market, but acknowledged the difficulties of balancing product variations with safety concerns.

For example, variation in the sets of instructions for uses of products dispensed through a pharmacy is potentially problematic, Badrul...

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US FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Rejects Vanda Citizen Petitions

 
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More from Biosimilars & Generics

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• By Dave Wallace

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EU Biosimilar Filings, Opinions And Approvals

 
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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.

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