Anticipation for the Food and Drug Administration’s continued rollout of a modernized and streamline OTC monograph program and a close watch on the possibility of the FDA imposing mandatory dietary supplement listing are priorities on the US consumer health’s regulatory radar for 2023.
US Consumer Health Industry In 2023: Monograph Results, Switch Hopes On OTC Drug Sector Radar
OTC drug and dietary supplement industry trade group executives discuss questions on potential market and regulatory developments affecting their members’ businesses. HBW Insight reports on OTC drug sector’s outlook for the FDA potentially publishing a final rule to expand switch opportunities as well as its anticipation of marketplace results from monograph program overhaul.
More from Regulation
• By
HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.
• By
Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.
• By
Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.
• By
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.
More from Policy & Regulation
• By
Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.
• By
A round-up of the latest industry moves in Europe: Pharma Deutschland elects board of new Brussels operation; MHRA's new CEO gets to work; Futura names non-executive director.
• By
“If this doesn’t get reauthorized, look at the number of the ingredients out there, the number of products, what would happen all those products out there for the consumer, on that shelf, in the drugstore or someplace?” says Rep. Bob Latta during House hearing.