Скачать или смотреть CMC Updates for Orally Inhaled Drugs (27of35) Complex Generics– Sep. 25-26, 2019

Fang Yuan, a chemistry reviewer in the Office of Pharmaceutical Quality (OPQ), provides an overview of orally inhaled drug products (OIDPs) to include pressurized metered dose inhalations (MDIs) and dry powder inhalations (DPIs). She shares unique quality issues and considerations associated with generic MDI and DPI submissions and common quality questions from pre-Abbreviated New Drug Application (ANDA) communication pathways.


Learn more at https://www.fda.gov/drugs/cder-small-...


_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities.

Email: [email protected]
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn:   / cder-small-business-and-industry-assistance  
Twitter:   / fda_drug_info  
CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...