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 UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
