The FDA issued new guidance for sponsors of drugs designed to treat hay fever as well as other cold-like symptoms that aren’t caused by allergies. In a pair of final guidances, the agency urges drug sponsors to focus on real-world settings when trying to determine doses.
Simplifying Global Compliance
FDA Releases Final Guidance on Drugs for Hay Fever, Non-Allergic Rhinitis
International Pharmaceutical Regulatory Monitor
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International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.
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International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.
PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.
With your subscription you’ll also receive:
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International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.
PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.
With your subscription you’ll also receive:
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- Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
- Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
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