Valisure Aims To Show DOD, Others Which Generics Are Best In NDC Screening And Color-Coding Pilot

DOD signs R&D agreement with lab to double check quality of given FDA-approved generic drugs prior to dispensing them. Pilot could help the military and others identify higher-quality sources. Meanwhile, Kaiser pilots Valisure certification requirement.

Dissolution testing
which generic dissolves best? • Source: Shutterstock

The US Defense Department’s recent agreement to study a private sector laboratory’s ability to assess generic drug quality could help drive the market toward higher-rated generics firms, one National Drug Code at a time.

More from Generics

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By 

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

Is Optum Rx Payment Remodel To Favor Generics A Peace Offering For US FTC?

 

Optum Rx, one of the largest PBMs in the US, declared it was the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.

Supreme Court May Be Next After Federal Circuit Refuses To Rehear Teva Inhaler Patents Case

 

Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

US FDA’s Speed Of Work Under Trump Quietly Raising Industry Concerns

 

Multiple sources, including former Acting FDA Commissioner Janet Woodcock, told the Pink Sheet that industry is quietly complaining about FDA work delays and they expect the problem will worsen.

More from Biosimilars & Generics

Surrogate Endpoint ‘Reasonably Likely’ Decision Process An ‘Uncertain Standard,’ Industry Says

 
• By 

The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.

Branded Pharma And Generics Industries At Odds Over UK VPAG Framework

 

The UK branded drug industry is calling for adjustments to be made to the UK voluntary scheme framework for branded medicines, after the payment rate increased to 22.9% for 2025. Meanwhile, the generics industry says the scheme is functioning “as intended” and opposes any changes.

Supreme Court May Be Next After Federal Circuit Refuses To Rehear Teva Inhaler Patents Case

 

Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?