Drug Industry Daily

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FDA and U.S. Pharmacopeial Convention (USP) officials say proactive industry participation — mainly by offering up drug samples and technical information — is vital to improving the quality of OTC finished drugs, the subject of recent high-profile recalls.

Reps. Tim Ryan (D-Ohio) and Nita Lowey (D-N.Y.) have introduced legislation aimed at ensuring patients with Celiac Disease or other gluten sensitivities can safely take FDA-approved drugs.

The FDA’s draft plan for implementing standard benefit-risk templates in drug reviews lacks a process for including patient concerns, the National Organization of Rare Diseases (NORD) says.

Both China and India are working to help makers of active pharmaceutical ingredients (API) satisfy the tough, new quality requirements in the EU’s Falsified Medicines Directive before the directive’s July 2 deadline.