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Generic Industry Specialization, Consolidation Driven By Rising Product Complexity

 
• By Derrick Gingery

The generic market is moving toward more complex products and formulations, which will separate companies based on capabilities, CEOs said at the Generic Pharmaceutical Association annual meeting.

Several generic industry CEOs see their sector placing more emphasis on combining resources in the coming years as increased product complexity forces companies to find a niche in the market.

Consolidation and alliances are expected to continue, in part because no one player will be able to collect all the expertise needed to develop more complex products, industry leaders said Feb

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• By Bridget Silverman

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• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.

More from North America

Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
• By Cathy Kelly

President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.