Citizen Petition On Phenylephrine Requests Pulling OTC Status For Children

A citizen petition asks FDA to withdraw OTC approval for phenylephrine use by children under 12 years old and to raise the maximum dose to 25 mg, but also recommends more research to determine the most effective dosage level

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More from Pink Sheet

New Measures Can Cut Israel’s Drug Approval Time To Just 70 Days

 

Israel has introduced a new framework to expedite the marketing approval of medicines, make the country a more attractive destination for drug registration and help reduce drug prices through market competition.

Global Pharma Guidance Tracker March 2025

 

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
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US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth