An upcoming US Food and Drug Administration workshop is on an OTC program established four years ago but might seem like it started only yesterday, its Over-the-Counter Monograph Drug User Fee program.
US FDA Asks For Comments On Reauthorizing OMUFA, A Program Still New To OTC Industry
Agency conducting all-day online meeting on 28 September to discuss proposed first reauthorization of OMUFA program established with its first five-year authorization in 2020 in legislation to overhaul the OTC monograph program.
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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.
• By
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.
• By
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.