Pregnancy Test Should Be Required For Accutane Rx, FDA Cmte. Urges
Documentation of a negative pregnancy test would be required before Accutane prescriptions could be filled under a risk management program recommended by FDA's Dermatologic and Ophthalmic Drugs Advisory Committee Sept. 18.
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BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.