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Patients with a history of skin disorders or those taking medications that increase photosensitivity should avoid direct sunlight and use sun protection
Rather than requesting procedural updates alone, FDA required: Independent data integrity investigations Interviews with current and former employees Three-year retrospective review of invalidated OOS results Comprehensive risk assessments Long-term CAPA programs Annual third-party CGMP audits Continuous oversight of microbiology testing for U.S
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PMID 16029679 Pharmaceutics
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