Hogan Lovells attorneys say FDA has difficult decisions ahead to implement an 11th Circuit Court of Appeals decision against the agencys established p...
FDA tells a House user fee reauthorization hearing that it is enthusiastic about new early interaction meetings for getting feedback on drug developme...
FDA issues a draft guidance on the content and format of immunogenicity information in therapeutic protein and select drug product labeling.
Eli Lilly delays a planned BLA accelerated approval submission for its Alzheimers investigational antibody therapy donanemab due to uncertainties rela...
President Biden re-launches his Cancer Moonshot with new goals and activities, including a cancer cabinet with FDA and other agencies.
FDA issues a draft guidance on policies and procedures for formal agency meetings with sponsors or requestors of OTC monograph drugs.
Two Hogan Lovells attorneys see an ongoing Department of Justice interest in telehealth fraud and electronic health records cases.