Children’s Hospital Resumes FDA-Funded Study Of PEG 3350 Pediatric Risks
New FDA assays may show whether polyethylene glycol laxative leaves toxic analytes and metabolites in children with chronic constipation – with potential implications for numerous other products.
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Driven by COVID-19 pandemic challenges, regulatory authorities from multiple regions want to work with sponsors on new joint approaches for expediting manufacturing changes globally and streamlining preapproval and pre-licensing inspections.
Proposed guidance revision adds nuance to manufacturing facility separation expectations for beta-lactam compounds that pose less risk of anaphylaxis than penicillin and related antibiotics.