by Pill Pals Customer Service | Oct 23, 2025 | News
Exceptions or additions to the recognized standards. For the bacteria listed below, susceptibility test interpretive criteria are not recognized at this time:Acinetobacter spp.Other Non-Enterobacterales Content current as of: 10/23/2025...
by Pill Pals Customer Service | Oct 23, 2025 | News
FDA has completed its review of the rationale document titled, “Aminoglycoside Breakpoints for Enterobacterales and Pseudomonas aeruginosa” submitted by the Clinical and Laboratory Standards Institute (CLSI) to the public docket FDA-2017-N-5925-0037 in January...
by Pill Pals Customer Service | Oct 23, 2025 | News
S = Susceptible; I = Intermediate; R = Resistanta. Susceptibility interpretive criteria are based on a dose of 6 grams fosfomycin every 8 hours by intravenous infusion over 1 hour in patients with an estimated creatinine clearance of 50 mL/min.b. For disk diffusion,...
by Pill Pals Customer Service | Oct 22, 2025 | News
Docket Number: FDA-2013-D-0446 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research FDA is posting this document to provide advance notice to the public. After the lapse in appropriations ends, a notice of availability for the guidance will be...
by Pill Pals Customer Service | Oct 22, 2025 | News
Docket Number: FDA-2022-D-1385 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health FDA is posting this document to provide advance notice to the public....
by Pill Pals Customer Service | Oct 22, 2025 | News
PodcastThank you for joining us for another episode of the Guidance Recap Podcast. My name is Kylie Haskins, and I am today’s host. In this episode, I am excited to be talking with two people from FDA’s Center for Drug Evaluation and Research, Dr. David Reasner, the...
by Pill Pals Customer Service | Oct 22, 2025 | News
Best Practices for Communication Between IND Sponsors and FDA During Drug DevelopmentFinal Guidance Updated guidance on best practices for communication between IND sponsors and FDA during drug development.Meeting Management Goals12/29/2017BsUFA II: Assessment of the...
by Pill Pals Customer Service | Oct 22, 2025 | News
Contents: Mission and PurposeThe Center for Drug Evaluation and Research (CDER) has a mission to ensure the availability of safe and effective medicines to improve public health in the United States. Recognizing that pharmaceutical development, manufacturing, and...
by Pill Pals Customer Service | Oct 21, 2025 | News
FDA is requiring labeling changes to strengthen the warnings that tranexamic acid injection should be administered only intravenously (into the vein). Tranexamic acid injection products are not to be administered intrathecally (into the spine) or as an epidural...
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