FDAnews Drug Daily Bulletin

UK May Allow Early Access to Drugs Based on Strong Phase II, III Trials

Aug. 27, 2012
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Strong Phase III or even Phase II data may enable drugmakers to sell certain medicines for unmet needs in the UK before they are approved, thanks to a developing early access program. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is proposing the scheme, which would provide access to promising new drugs about a year before they are brought to market.
Clinical Trials Advisor