Wednesday, March 26, 2014

Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Request for Nominations--31 Comments Now Available for Public Viewing

Comment from Biogen Idec, Inc.
null
  • See Attached
  • Public Submission
  • Posted:
    03/10/2014
  • ID:
    FDA-2013-N-1523-0008
  • Organization:
  • Submitter Name:


Comment from Kenneth Woliner, MD
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  • NOMINATION: Human Chorionic Gonadotropin (hCG) in any dosage form not injectable (i.e. it is "difficult to compound" hCG in oral, sublingual, intranasal, and topical delivery...
  • Public Submission
  • Posted:
    02/06/2014
  • ID:
    FDA-2013-N-1523-0002
  • Organization:
  • Submitter Name:

Comment from the Arachnoidis Society for Awareness and Prevention
null
  • See Attached
  • Public Submission
  • Posted:
    03/07/2014
  • ID:
    FDA-2013-N-1523-0007
  • Organization:
  • Submitter Name:

Comment from AnazaoHealth
null
  • See attached file(s)
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0030
  • Organization:
  • Submitter Name:

Comment from Biotechnology Industry Organization (BIO)
null
  • See attached file(s)
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0029
  • Organization:
  • Submitter Name:

Comment from PharMEDium Services
null
  • See attached file(s)
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0021
  • Organization:
  • Submitter Name:

Comment from Aptalis Pharma US, Inc.
null
  • See Attached
  • Public Submission
  • Posted:
    03/10/2014
  • ID:
    FDA-2013-N-1523-0009
  • Organization:
  • Submitter Name:

Comment from GlaxoSmithKline (GSK)
null
  • See attached file(s)
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0019
  • Organization:
  • Submitter Name:

Comment from National Home Infusion Association (NHIA)
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  • The National Home Infusion Association (NHIA) submits these comments on the draft guidance made available on December 4, 2013 by the Food and Drug Administration (FDA) entitled...
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0018
  • Organization:
  • Submitter Name:

Comment from Acorda Therapeutics, Inc.
null
  • See attached file
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0017
  • Organization:
  • Submitter Name:

Comment from Public Citizen
null
  • See attached file(s)
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0028
  • Organization:
  • Submitter Name:

Comment from The American Society of Health-System Pharmacists (ASHP)
null
  • Please see ASHP's comments in the attached file
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0016
  • Organization:
  • Submitter Name:

Comment from Terri Anderson
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  • Arachnoiditis Society for Awareness and Prevention (ASAP) Offices located in Montana, South Carolina and Florida Submitted by Terri Anderson Harmed Civil Engineer, Patient...
  • Public Submission
  • Posted:
    03/11/2014
  • ID:
    FDA-2013-N-1523-0010
  • Organization:
  • Submitter Name:

Comment from Peter Parsonson
null
  • Please see the attached request for nomination for a drug product that presents demonstrable difficulties for compounding under Sections 503A and 503B of the Act.
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0015
  • Organization:
  • Submitter Name:

Comment from Kenneth Woliner, MD
  • NOMINATION: Compounded Oral Itraconazole (Sporanox) WHY IS THIS DRUG BEING NOMINATED: Gigi Davidson, RPh, explains it better than I can, but simply put, ORAL itraconazole is NOT...
  • Public Submission
  • Posted:
    02/06/2014
  • ID:
    FDA-2013-N-1523-0004
  • Organization:
  • Submitter Name:

Comment from FaegreBD
null
  • Please see comments in attached file.
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0027
  • Organization:
  • Submitter Name:

Comment from Nephron
null
  • See attached file(s)
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0026
  • Organization:
  • Submitter Name:

Comment from Mallinckrodt Pharmaceuticals
null
  • see attached
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0031
  • Organization:
  • Submitter Name:

Comment from AbbVie
null
  • Comments from AbbVie
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0025
  • Organization:
  • Submitter Name:

Comment from Auxilium Pharmaceuticals
null
  • NOMINATION: INJECTABLE ERECTILE DYSFUNCTION DRUGS CONTAINING ALPROSTADIL SUBMITTED BY: AUXILIIUM PHARMACEUTICALS, INC. AGENCY: FDA DOCKET NO.: FDA-2013-N-1523 ATTACHMENTS...
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0022
  • Organization:
  • Submitter Name:

Comment from George Suarez
null
  • Please see my attached letter for my comments.
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0013
  • Organization:
  • Submitter Name:

Comment from PharMEDium Services
null
  • See attached file(s)
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0020
  • Organization:
  • Submitter Name:

Comment from Anonymous
  • Men’s Health Network (MHN) would like to nominate implantable testosterone pellets for inclusion on the difficult-to-compound list to be developed by the FDA. As an organization...
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    FDA-2013-N-1523-0032
  • Organization:
  • Submitter Name:

Comment from Kenneth Woliner, MD
  • NOMINATION: COMPOUNDED HORMONE PELLETS a.k.a. BHRT Fused Pellets Implants (SottoPelle; Armor Vie; other brand names) BACKGROUND: I am a board-certified family medicine physician...
  • Public Submission
  • Posted:
    02/06/2014
  • ID:
    FDA-2013-N-1523-0003
  • Organization:
  • Submitter Name:

Comment from Kenneth Sekine, MD
  • : FDA and Docket NO. FDA-2013-N-1523 I have been practicing gynecology for 33 yrs. and presently have a very large patient base of menopausal women. I have been prescribing HRT...
  • Public Submission
  • Posted:
    03/21/2014
  • ID:
    Comment from Auxilium Pharmaceuticals
    null
    • NOMINATION: INJECTABLE ERECTILE DYSFUNCTION DRUG COMBINATIONS CONTAINING PAPAVERINE SUBMITTED BY: AUXILIUM PHARMACEUTICALS, INC. AGENCY: FDA DOCKET NO.: FDA-2013-N-1523...
    • Public Submission
    • Posted:
      03/21/2014
    • ID:
      FDA-2013-N-1523-0024
    • Organization:
    • Submitter Name:
    Comment from Auxilium Pharmaceuticals
    null
    • NOMINATION: IMPLANTABLE TESTOSTERONE PELLETS SUBMITTED BY: AUXILIUM PHARMACEUTICALS, INC. AGENCY: FDA DOCKET NO.: FDA-2013-N-1523 ATTACHED: Nomination document; Exhibits
    • Public Submission
    • Posted:
      03/21/2014
    • ID:
      FDA-2013-N-1523-0023
    • Organization:
    • Submitter Name:
    Comment from Kythera Biopharmaceuticals Incorporated
    null
    • See Attached
    • Public Submission
    • Posted:
      03/20/2014
    • ID:
      FDA-2013-N-1523-0012
    • Organization:
    • Submitter Name:
    Comment from Stephen Byrn
    null
    • See attached file(s)
    • Public Submission
    • Posted:
      02/06/2014
    • ID:
      FDA-2013-N-1523-0005
    • Organization:
    • Submitter Name:
    Comment from Sarah Sellers, q-Vigilance, LLC
    null
    • The attached nomination and comment is respectfully submitted by Sarah Sellers, PharmD MPH, President, q-Vigilance, LLC
    • Public Submission
    • Posted:
      03/07/2014
    • ID:
      FDA-2013-N-1523-0006
    • Organization:
    • Submitter Name:
    Comment from the National Home Infusion Association
    null
    • See Attached
    • Public Submission
    • Posted:
      03/13/2014
    • ID:
      FDA-2013-N-1523-0011
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