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.
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.

More from Generics
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?
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.
The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.
Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.
More from Biosimilars & Generics
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.
Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”
The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.