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Italian regulatory authorities have cited two Indian drugmakers for dozens of GMP issues, ranging from data security to quality management issues. Read More
A Puerto Rican drugmaker has landed a 13-observation Form 483 over numerous GMP procedural issues and a lack of oversight at its plant in Salinas. Read More
The Secretary’s Advisory Committee on Human Research Protections is recommending revisions to the Common Rule that would provide further guidance on single IRB reviews. Read More