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Remembering Reginald “Reggie” Fant, 1967-2020

Dr. Reginald V. Fant (“Reggie”) died unexpectedly Sunday, September 27, 2020, following complications of a stroke. He was the Director of Clinical Pharmacology and Abuse Potential Assessment at PinneyAssociates (PA), in Bethesda, Maryland, where he worked for over 23 years. He led many of PA’s abuse potential assessments of medicines in development. Dr. Fant’s efforts... Read more »... Read More >

Implementation of Consistent Language as Outlined in FDA Draft Guidance on Drug Abuse and Dependence Labeling Will Support Drug Development, Labeling and Prescriber Decision-Making

By Jack Henningfield, Karen Gerlach, Judy Ashworth, Marion Coe, Sid Schnoll Once finalized, FDA Draft Guidance “Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format” will help ensure more consistent language across drug products about abuse, misuse, addiction, dependence, and tolerance. Our experts in the development... Read more »... Read More >

Regulatory Case Study: A Strategic Abuse Potential Assessment of Acorda Therapeutics’ INBRIJA™ (levodopa inhalation powder)

By Reggie Fant In December 2018, the Food and Drug Administration (FDA) approved Acorda Therapeutics’ INBRIJA, the first levodopa inhalation powder for the intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa. As Parkinson’s disease progresses, many people with Parkinson’s fluctuate between ON periods, during which symptoms are controlled and OFF... Read more »... Read More >