Taro Pharms Generic Imiquimod Receives Approval In US
EMA has completed its review of Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, and concluded that the medicine may increase the risk of skin cancer and that its risks outweigh its benefits.
Enforcement Report - Week of February 28, 2018
The Trump administration has indicated plans to reform the U.S. Food and Drug Administration (FDA) “to put greater focus on the need of patients for new and innovative medical products.” So far, it hasn’t selected a commissioner for the FDA, although some of the names suggested, such as Jim O’Neil, a venture capitalist, and Balaji Srinivasan, co-founder of genetics testing company Counsyl, have showed indications that they want to focus on drug safety rather than efficacy, perhaps even cutting the need for in-depth Phase III clinical trials.