Andrew Langowski

Andrew has more than 25 years of experience as a small molecule CMC review chemist performing both regulatory and scientific review of drug product applications, supplements and drug master files. His expertise covers a wide variety of drug substances and drug products. Dosage forms include low dose drugs, narrow therapeutic index drugs, solid orals, injectables, complex dosage forms (including transdermal and modified release) some of which were first generic approvals and associated with the following therapeutic categories: Oncology, anti-ulcer, narcotic analgesic, NSAID, sedative, peptides, cardiovascular, corticosteroids, antibiotics,
anti-retroviral, anti-asthmatic, anti-histaminic, anti-depressant, anti-epileptic, anti-Alzheimer and drug/device combination products.

Work experience

Andrew is a prior member of numerous Agency, Center and Office-level FDA Technical Committees and Working Groups including: CDER Packaging Guidance (Container Closure Systems for Packaging Human Drugs and Biologics); Common Technical Document-Quality (CTDQ container-closure sections); CMC Question Based Review (QBR-QOS) and assessment lead and co-drafter of the (2018) FDA Guidance for Industry: Drug Substance Post-Approval Changes. Prior to his role as a CMC Review Chemist, Andrew spent over five years as Branch Chief at FDA’s Office of Lifecycle Drug Products (OLDP).

Education

Andrew holds a BA in Chemistry from St. Mary’s University, Minnesota and a Ph.D. in Chemistry-(ABD) from George Washington University, Washington D.C. Furthermore he completed a certificate in Pharmaceutics from University of Maryland, Baltimore School of Pharmacy.