jwgilbreathOct 105 min readNew Exemptions..DSCSA-October 2024Hello all… As you may have already heard, the FDA has announced more exemptions for authorized trading partners. For this post I will...
jwgilbreathFeb 291 min readDSCSA—CDER NextGen Portal. Follow upHello all! So, as a follow up regarding the CDER NextGen Portal: As I stated in an earlier post, the portal is used as a communication...
jwgilbreathDec 5, 20231 min readFDA CDER NextGen Portal UpdateHello all! I have been communicating with one of the FDA help lines for made clarity related to the CDER NextGen portal. The...
jwgilbreathNov 29, 20232 min readFDA CDER Site for DSCSAHello all! So, FDA has added to their Centers for Drug Evaluation and Research (CDER) internet site (I.e., their "CDER NextGen" Portal). ...
jwgilbreathAug 20, 20231 min readMore DSCSASorry everybody.... I've been very tied up at work lately so have not been focusing on the blog. Decided to jump on and post a very,...
jwgilbreathMay 27, 20233 min readDSCSA — Suspect and Illegitimate ProductsWelcome back to the blog! Let's discuss one of the core reasons why DSCSA was formulated ...suspect and illegitimate products. FDA has...