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The FDA is proposing a surveillance plan for Merck’s Gardasil 9 to screen for four potential adverse risks associated with human papillomavirus vaccines. Read More
Drugmakers are expected to collect individual cases of suspected adverse reactions linked to off-label use but not individual reports when there has been no associated adverse event, the EMA said in April. Read More
Swedish authorities withdrew the EU-GMP certificate for Capsugel’s Bend Research on Monday for repeated GMP violations, including data integrity issues. Read More