FDAnews Drug Daily Bulletin

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

Aug. 27, 2012
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