The number of OTC drugs on the US Food and Drug Administration’s monthly list of labeling changes for approved new drug applications and ANDAs should shrink as the agency advises firms on changes which can be notified in annual reports.
US FDA Wants ‘Minor’ Labeling Changes For OTCs Available Through NDAs/ANDAs In Annual Reports
Fewer labeling changes submitted for OTC NDAs/ANDAs makes more time available for CDER reviews of other applications for OTC switches as well as non-minor labeling changes to nonprescription drugs plus far larger number of submissions for Rx drug approvals and labeling.
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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.