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CPG Sec. 270.100 Final Container Labels

by Pill Pals | Oct 26, 2024 | News

Issued by: Guidance Issuing Office Office of Regulatory Affairs Compliance Policy Guide 270.100 Final Container Labels – Allergenic Extracts Containing Glycerin; Reporting Changes is obsolete and was withdrawn on 1/30/2020. Issued: 7/19/76Revised: 10/1/80,...

CPG Section 110.800 Post Detention Sampling Guidance for Industry

by Pill Pals | Oct 26, 2024 | News

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 – Specific Electronic Submissions Intended For FDA’s Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other...

CPG 230.120- Human Blood and Blood Products as Drugs

by Pill Pals | Oct 26, 2024 | News

Issued by: Guidance Issuing Office Office of Regulatory Affairs Compliance Policy Guide Sec. 230.120- Human Blood and Blood Products As Drugs is obsolete and was withdrawn on 1/30/2020. Issued 6/17/74Revised 10/1/80Withdrawn: 1/30/2020 Submit Comments Submit...

CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunte

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...

CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program A

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...

Sulopenem etzadroxil and probenecid – Oral Products

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....