FDA Proposes “Sinusitis” Exclusion From OTC Nasal Decongestant Monograph

FDA is seeking to amend the OTC nasal decongestant monograph by removing the indications that reference "sinusitis," the agency announced in a proposed rule slated for publication in the Aug. 2 Federal Register

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Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

Senate Panel Approves US CDC Director Candidate Monarez With Measles Outbreak Growing

 
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The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.

US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality

 
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The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.