FDA Guidance and New Drug Approvals

Center for Drug Evaluation and Research. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products. Date unknown. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/default.htm. Accessed April 20, 2018

Reuters. 2017 Saw the Most New Drugs Approved in Over 20 Years. http://fortune.com/2018/01/02/new-drug-approvals/. Published January 2, 2018. Accessed April 20, 2018.

U.S. Food and Drug Administration. Remarks From FDA Commissioner Scott Gottlieb, M.D. on Fiscal Year 2019 Budget Request for FDA. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604826.htm. Published April 17, 2018. Accessed April 20, 2018.

U.S. Food and Drug Administration. Statement From FDA Commissioner Scott Gottlieb, M.D. on Advancing the Development of Novel Treatments for Neurological Conditions; Part of Broader Effort on Modernizing FDA’s New Drug Review Programs. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596897.htm Published February 15, 2018. Accessed April 20, 2018.

Center for Drug Evaluation and Research. Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for Industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM450229.pdf. Published February 2018. Accessed April 20, 2018.

Center for Drug Evaluation and Research. Migraine: Developing Drugs for Acute Treatment Guidance for Industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM419465.pdf. Published February 2018. Accessed April 20, 2018.

Center for Drug Evaluation and Research. Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM596728.pdf. Published February 2018. Accessed April 20, 2018.

Center for Drug Evaluation and Research. Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM596718.pdf. Published February 2018. Accessed April 20, 2018.

Center for Drug Evaluation and Research. Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy From Adults to Pediatric Patients 4 Years of Age and Older Guidance for Industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM596731.pdf. Published February 2018. Accessed April 20, 2018.

Gever J . FDA Eases Approval Path for Migraine, Pediatric Epilepsy Drugs. https://www.medpagetoday.com/neurology/generalneurology/71209. Published February 16, 2018. Accessed April 20, 2018.

Jack CR Jr Bennett DA Blennow K et al . NIA-AA research framework: toward a biological definition of Alzheimer’s disease. Alzheimers Dement. 2018;14(4):535-562.

Knopman DS Haeberlein SB Carrillo MC et al . The National Institute on Aging and the Alzheimer’s Association Research framework for Alzheimer’s disease: Perspectives From the Research Roundtable. Alzheimers Dement. 2018;14(4):563-575.

Biohaven Pharmaceutical Holding Company Ltd. Biohaven Announces Successful Achievement of Both Co-Primary Regulatory Endpoints in Two Pivotal Phase 3 Trials of Rimegepant an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine. Date unknown. https://www.prnewswire.com/news-releases/biohaven-announces-successful-achievement-of-both-co-primary-regulatory-endpoints-in-two-pivotal-phase-3-trials-of-rimegepant-an-oral-cgrp-receptor-antagonist-for-the-acute-treatment-of-migraine-300619129.html. Accessed April 20, 2018

Allergan plc. Allergan Announces Positive Top Line Phase 3 Results for Ubrogepant—An Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine. Date unknown. https://www.prnewswire.com/news-releases/allergan-announces-positive-top-line-phase-3-results-for-ubrogepant–an-oral-cgrp-receptor-antagonist-for-the-acute-treatment-of-migraine-300593912.html. Accessed April 20, 2018.

Eli Lilly and Company. Lilly Announces Positive Results for Second Phase 3 Study of Lasmiditan for the Acute Treatment of Migraine. Date unknown. https://www.prnewswire.com/news-releases/lilly-announces-positive-results-for-second-phase-3-study-of-lasmiditan-for-the-acute-treatment-of-migraine-300499684.html. Accessed April 20, 2018.