Despite delivering only four switches in 10 years, the European Union’s centralized switch procedure was defended by the EMA's Zaide Frias at AESGP's March regulatory conference. Frias pointed to the recent success of HRA Pharma's EllaOne, to the role of pharmacists in driving switches and to the possibility of an OTC Expert Forum as ways forward for the procedure.
Delivering only four prescription-to-OTC re-classifications in the last decade, the European Union’s (EU’s) centralized switch procedure is viewed by some as a failure.
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After the product’s initial launch in May 2024, California’s government has now expanded the availability of its CalRx-branded generic OTC Narcan to all of its citizens.
HBW Insight catches up with UK OTC industry association CEO Michelle Riddalls to talk about digital self-care and the unrealized promise of Brexit - part 2.
Reps. Latta, Crenshaw and Miller-Meeks contend language in ACNU final rule preamble would allow a sponsor of an approved application to litigate to halt Rx availability of same formulation and “risk eliminating the very rule on which its product approval was based.”
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.
Being poor makes it more likely that you will suffer from self-treatable health conditions but it also means you will find it harder to take advantage of self-care solutions, finds a recently-published study by Bayer Consumer Health and IQVIA.
Concern is unavoidable for most marketers of OTC drugs and dietary supplements in the US. As Canaccord Genuity analysts said in a 15 April research note, “uncertainty remains about how the tariff situation will play out.”
HBW Insight catches up with UK OTC industry association CEO Michelle Riddalls to talk about digital self-care and the unrealized promise of Brexit - part 2.
