The authors of a citizen petition say researchers have met a bar FDA set for studies showing oral phenylephrine is not effective as a nasal decongestant and should be removed from the OTC monograph.
Petition Answers FDA Questions On Oral Phenylephrine Efficacy, Suggests Removal From Monograph
A citizen petition says studies have answered the question FDA and advisory committee members asked in 2007, for studies on the most effective dose of PE as a nasal decongestant. The studies show “PE is no more effective than placebo,” the petition says.
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Some FDA employees who were recently laid off by the Trump Administration are being called back to work, multiple sources confirmed to the Pink Sheet.
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The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”
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The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”
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US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.
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Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.