by Pill Pals | Oct 26, 2024 | News
Issued by: Guidance Issuing Office Office of Regulatory Affairs CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor Submit Comments Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 – Specific...
by Pill Pals | Oct 26, 2024 | News
Issued by: Guidance Issuing Office Office of Regulatory Affairs Document Release Date: June 2, 2007 This document supersedes Compliance Policy Guide (CPG) “Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (CPG...
by Pill Pals | Oct 26, 2024 | News
Minimum Inhibitory Concentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacteralesa ≤ 0.25 0.5 ≥ 1.0 ≥ 19 16-18 ≤ 15 S = susceptible; I = intermediate; R = resistant a Clinical efficacy was shown for E. coli, K. pneumoniae, and P....
by Pill Pals | Oct 26, 2024 | News
Author affiliation: University of Oklahoma Health Sciences, Oklahoma City, Oklahoma, USA Figure 1Figure 1. Geography of Oklahoma, USA, and population by county (range 2,137–797,434 residents). Counties with thick boundary lines are metropolitan. The 2 most populous...
by Pill Pals | Oct 26, 2024 | News
Issued by: Guidance Issuing Office Office of Regulatory Affairs Center for Drug Evaluation and Research, Office of Regulatory Policy BACKGROUND: The House Subcommittee on Oversight and Investigations began an investigation of wrongful acts involving some manufacturers...
by Pill Pals | Oct 26, 2024 | News
This web page provides information about the in vitro susceptibility of bacteria to certain drugs. The safety and efficacy of these drugs in treating clinical infections due to such bacteria may or may not have been established in adequate and well-controlled clinical...
by Pill Pals | Oct 26, 2024 | News
Author affiliation: Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, Georgia, USA (A. Bratcher); Alan Shawn Feinstein College of Education, University of Rhode Island, Kingston, Rhode Island, USA (S.-Y. Kao); Labcorp Esoterix,...
by Pill Pals | Oct 26, 2024 | News
Issued by: Guidance Issuing Office Office of Inspections and Investigations Compliance Policy Guide Guidance for FDA staff and Industry CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs November 2004 Preface Public...
by Pill Pals | Oct 26, 2024 | News
Amikacin Injection FDA does not recognize M100 standard (MIC and disk diffusion) for Enterobacterales and Pseudomonas aeruginosa Antibacterial 4/21/2023 Amoxicillin and clavulanate Oral FDA does not recognize M100 standard and provides STIC for Haemophilus influenzae....
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