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Teva Pharmaceuticals USA Inc.

Latest From Teva Pharmaceuticals USA Inc.

Quality Officers Call For New Approaches To Reduce Global Manufacturing Change Complexity

Pharmaceutical quality leadership proposes eight-step “dance” with complex global regulatory system for allowing manufacturing processes to improve more quickly. The data showed many authorities take more than the recommended six months to decide on post-approval changes, with assessments taking almost eight years in some cases.

Manufacturing Quality

In Washington, The Answer Is Drug Shortages But What Is The Question?

They’re all probing the drug shortage problem, each with a different line of inquiry: the Federal Trade Commission and the Health and Human Services Department, House Oversight Committee Democrats, and the bipartisan leadership of the Senate Finance Committee.

Manufacturing Market Access

‘We Did Too Good Of A Job’ On Lowering Prices: Sandoz’s Haruvi Discusses Generic Sustainability

As Hatch-Waxman celebrates its 40th anniversary, the chair of the US generic trade association talks about striking the right balance on supply and pricing, preventing shortages, and improving Medicare price negotiations.

Generic Drugs Biosimilars

Trade Secrets In Court: Are Dissolution Specifications That FDA Gave Vanda Proprietary?

Court of Federal Claims lets Vanda’s suit against the agency go forward but notes a ruling for the company could undermine FDA’s ability to provide assistance to other brand name and generic manufacturers.

Generic Drugs Legal Issues
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