Feature articles over the past weeks have focused on the ability to assess and manage the benefit-risk profile of drugs, rules for updating prescription drug labels, off-label communications efforts, FDA’s role in regulating the advertising and promotion of prescription drugs, biologics and medical devices, the challenges of regulating mobile applications versus computers systems and recommendations for measuring regulatory compliance of complementary medicines. Researching and planning of clinical endpoints, including navigating through FDA’s understanding and interpretation of laws and definitions is also covered.
Benefit-Risk Management
Ensuring the benefits associated with a drug product’s use outweigh its risks is an important concern for regulators and regulatory professionals alike. Over the past decade, the ability to assess and manage the benefit-risk profile of drugs has been significantly enhanced by several important new additions to the benefit-risk management “toolkit” in addition to the inclusion of patient experience. Global risk management experts Meredith Y. Smith, Hilda W. Chan, Carmit Strauss, Kimberley Hockley and Andrea Russell provide an overview of…
