Regulatory Affairs

FDA Wants Hormonal Products Assessed for Environmental Harm

Drugmakers seeking approval of products with hormonal effects should submit an assessment with their applications that evaluates whether they would be harmful if released into the environment. The requirement, spelled out in draft guidance Tuesday, would apply to drugs with estrogenic, androgenic or thyroid activity. Read More

HHS Protects ZMapp from Legal Liability

HHS has promised to protect the maker of the experimental Ebola virus drug ZMapp from legal liability, meaning the company can’t be sued for claims of injury or loss related to use of the monoclonal antibody cocktail. Read More