DSCSA—Small Dispensers
Hello all, On June 12, 2024, the FDA announced DSCSA exemptions for certain types of dispensers (i.e., “small dispensers”) until November...
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jwgilbreath
May 171 min
DSCSA Mid Point
Hello All! We are coming up to the midpoint of the FDAs stabilization period allowed for the industry to prepare for DSCSA compliance. ...
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jwgilbreath
Jan 142 min
Verification Systems —DSCSA
I know it's been a while since my last post...the holidays plus traveling a lot for work! So, the FDA did puboish new guidance in...
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jwgilbreath
Dec 5, 20231 min
FDA CDER NextGen Portal Update
Hello all! I have been communicating with one of the FDA help lines for made clarity related to the CDER NextGen portal. The...
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jwgilbreath
Nov 29, 20232 min
FDA CDER Site for DSCSA
Hello all! So, FDA has added to their Centers for Drug Evaluation and Research (CDER) internet site (I.e., their "CDER NextGen" Portal). ...
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jwgilbreath
Nov 20, 20231 min
DSCSA Stabilization Period
Hello all!! Remember we are about to enter into the “stabilization period” established by the FDA for DSCSA compliance. This is November...
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jwgilbreath
Sep 26, 20231 min
DSCSA —where are you now?
Hello all!! With the FDA information about stabilization period for DSCSA in mind.... Are you pushing forward with your plans to be fully...
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jwgilbreath
Aug 30, 20231 min
DSCSA—November 27, 2024
Hello all! I'm attending the HDA traceability Seminar. Very interesting information. A couple FDA representatives are at the Seminar. ...
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jwgilbreath
Aug 27, 20231 min
DSCSA —extension
Hello all! I decided to put this blog here sort of as a place holder. This is just a reminder that the FDA has decided to extend the...
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