Research results mean different things to the different sides of the argument about oral phenylephrine’s efficacy as a nasal decongestant, a discussion which could decide whether the ingredient remains available for the indication in the US under an OTC monograph.
Oral Phenylephrine Study Results Spell Nasal Decongestion Failure To Critics, GRASE To Industry
FDA officials, joined by supporters of deeming ingredient non-GRASE, note problems with research referenced in initial GRASE designation. CHPA explained studies used to support GRASE designation for phenylephrine hydrochloride in 1976, for addition of bitartrate salt in 2006 and other results published since show ingredient’s efficacy for nasal decongestion.
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Reclassifying ethanol as a carcinogenic, mutagenic, or reprotoxic substance - something the European Chemicals Agency seems likely to do in the near future - would be “tantamount to a de facto ban” with “fatal consequences” for medical care in Germany, says Pharma Deutschland in a joint paper with 13 other German healthcare industry associations.
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Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.
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HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.