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The framework consists of 2 documents that expand on the agency’s plans for its risk-based approach for describing drugs, devices, and biologics, including those designated as regenerative medicine advanced therapies.
Pouya Ghaemmaghami, PhD: Predicted Gene Expression and the Association with Sleep Macrostructure
FDA Accepts NDA for Pitolisant for Excessive Daytime Sleepiness, Cataplexy in Narcolepsy
When It Comes to Sleep, Perception Is Everything
Lemborexant Shows Positives for Treating Insomnia at Six Months
Jeffrey Gudin, MD; Jeffrey Bettinger, PharmD
Zarazuela Zolkipli-Cunningham, MBChB, MRCP; Mary Kay Koenig, MD; Perry Shieh, MD, PhD, FAAN, FANA
James F. Howard Jr, MD, FAAN
Basil T. Darras, MD
Karissa Gable, MD
Anne M. Connolly, MD, FAAN; Amy Moore, PhD
Jessica Oswald, MD, MPH; Jeremy A. Adler, DMSc, PA-C; Amanda Nasser, MS, NP