France launching regulatory process for off-label use
France is implementing a regulatory process to temporarily authorize the use of selected drugs in off-label indications, according to a paper published in The New England Journal of Medicine by members of the country's revamped drug regulatory agency.
Under the process, health experts that do not represent the drug manufacturer may recommend a drug to the agency for off-label use in an indication for which there are no approved therapies. The drug manufacturer will then have three months to submit information on the drug in the off-label indication. The National Agency for the Safety of Medicines and Health Products (ANSM) can then issue a temporary recommendation for use (TRU) that would officially authorize the off-label use of the drug for up to three years. ANSM said companies should gather safety and efficacy data from clinical practice to support an application for full approval at the end of the three years. ...