FDA to Hold Workshop on Generic Orally Inhaled and Nasal Drug Products

Because we spend such a significant amount of our time on the development of complex drug products (whether 505(j) or 505(b)(2) submissions), any workshop that includes discussion of new methods for characterizing and demonstrating equivalence tends to get our attention. CDER/OGD will be hosting Generic Orally Inhaled and Nasal Drug Products Workshop on January 9, 2018 (8:30 a.m. – 4:30 p.m.), at the White Oak Campus. The workshop is free to attend and open to the public. Here’s the full story, including registration info, and here’s a link to a paper we recently wrote on the topic of complex generics.