Wednesday, September 3, 2014

17 comments made to Draft Guidance for Industry on Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act; Availability

Comment from PharMEDium Services
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  • Attached please find comments to the Draft Guidance for Industry on Current Good Manufacturing Practice - Interim Guidance for Human Drug Compounding Outsourcing Facilities
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0018
  • Organization:
  • Submitter Name:


Comment from Advanced Pharma
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  • See attached file(s)
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0004
  • Organization:
  • Submitter Name:

Comment from John Chapman
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  • Hello. I am submitting this in an effort to get some review on the suggestion for daily viable and non viable testing, specifically : Environmental monitoring should consist of a...
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0005
  • Organization:
  • Submitter Name:

Comment from Product Quality Research Institute (PQRI)
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  • The Product Quality Research Institute (PQRI) welcomes the opportunity to provide comments on the recent draft FDA Guidance for Industry entitled â??Current Good Manufacturing...
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0011
  • Organization:
  • Submitter Name:

Comment from Mayo Clinic Rochester
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  • Please refer the attached Word document for comments submitted by Mayo Clinic Pharmacy Services. Thank you for the opportunity to participate in this effort.
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0008
  • Organization:
  • Submitter Name:

Comment from The Pew Charitable Trusts
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  • See attached file(s)
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0012
  • Organization:
  • Submitter Name:

Comment from International Academy of Compounding Pharmacists
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  • Thank you for the opportunity to submit our comments on the Food and Drug Administrations withdrawal of a proposed rule and publication of a new proposed rule entitled Draft...
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0019
  • Organization:
  • Submitter Name:

Comment from Generic Pharmaceutical Association
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  • Comments of the Generic Pharmaceutical Association regarding Docket No. FDA-2014-D-0779-0001. See attached file.
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0014
  • Organization:
  • Submitter Name:

Comment from Parenteral Drug Association
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  • The Parenteral Drug Association has reviewed the draft guidance, supports FDAs efforts to clarify GMP requirements for compounding pharmacies, but has reservations regarding this...
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0006
  • Organization:
  • Submitter Name:

Comment from Baxter International
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  • See attached file(s)
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0017
  • Organization:
  • Submitter Name:

Comment from Alfonse Muto
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  • Attached is the file for comment on interim guidance for 503B facilities
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0003
  • Organization:
  • Submitter Name:

Comment from American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.)
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  • See attached letter of comment on Draft Guidance for Industry on Current Good Manufacturing PracticeInterim Guidance for Human Drug Compounding Outsourcing Facilities Under the...
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0010
  • Organization:
  • Submitter Name:

Comment from Catholic Health Initiatives
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  • See attached comment letter.
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0009
  • Organization:
  • Submitter Name:

Comment from National Home Infusion Association
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  • The National Home Infusion Association (NHIA) is pleased to submit the attached comments in response to the proposed rule published in the Federal Register on July 2, 2014 entitled...
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0013
  • Organization:
  • Submitter Name:

Comment from Biotechnology Industry Organization
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  • See attached file(s)
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0016
  • Organization:
  • Submitter Name:

Comment from ASHP
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  • Please refer to ASHP's comments in the attached file
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0015
  • Organization:
  • Submitter Name:

Comment from Microbiologics
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  • Please see attached comments from Microbiologics.
  • Public Submission
  • Posted:
    09/03/2014
  • ID:
    FDA-2014-D-0779-0007
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