Two academic researchers urge FDA to require a Drug Facts box in direct-to-consumer ads so consumers can understand a drug’s benefits and risks.
FDA urges the Supreme Court to reject Vanda Pharmaceuticals’ petition challenging the agency’s decision to deny fast-track status for its experimental drug tradipitant for gastroparesis.
Two academic researchers urge FDA to require a Drug Facts box in direct-to-consumer ads so consumers can understand a drug’s benefits and risks.
FDA urges the Supreme Court to reject Vanda Pharmaceuticals’ petition challenging the agency’s decision to deny fast-track status for its experimental drug tradipitant for gastroparesis.
Hyman, Phelps & McNamara principal medical device regulation expert Adrienne Lenz says FDA is preparing for a future where artificial intelligence and real-world evidence work together to deliver better patient outcomes and more efficient innovation pathways.
FDA accepts for priority review a Johnson & Johnson supplemental NDA for Akeega (niraparib and abiraterone acetate dual-action tablet) plus prednisone for treating BRCA-mutated metastatic castration-sensitive prostate cancer.
