Emergency contraceptive could be considered for Rx-to-OTC switch in the coming years, the company indicates. The Rx kit, which includes four levonorgestrel .25 mg/ethinyl estradiol .05 mg pills as well as a pregnancy test and a patient information book, received FDA approval Sept. 2. Speaking at a same-day teleconference, Gynetics Chairman Roderick Mackenzie did not express an immediate desire to pursue a switch, citing market research showing women value the chance for product reimbursement and physician consultation, but said the company would "monitor this together with FDA for the next year or two. As we learn more, we are going to readdress the situation of whether going over-the-counter is appropriate." Rx Preven will be available nationwide in late September; a print/radio consumer ad campaign is planned for October. FDA has shown mild interest in oral contraceptives as switch candidates. An advisory meeting on the topic was scheduled for February 1993, but was postponed to gather input from interested groups...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.
