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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
MiMedx is suing wound-treatment competitor Osiris Therapeutics, accusing it of falsely claiming in a press release that its biologic is superior to MiMedx’s product. Read More