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2016 PDA Regulatory Comments

  • PDA Response to WHO PAC for Biotherapeutic Products December 19, 2016
    PDA recommends this guideline be fully aligned with concepts in ICH Q12 once finalized and with ICH Q10 Annex 1. Also, biotech products are well characterized and should not require the same duration of review as complex vaccines. Finally, the guidance as currently written does not clearly address the post approval regulatory pathway for any improvements in potency assays for biotechnology products. This is a critical gap that should be addressed.
  • EMA QA Production of WFI by Non Distillation Methods Submitted 4 Nov 2016
    PDA fully supports the implementation of non-distillation methods for WFI production into the European regulatory framework and endorses the premise that non-distillation technology for producing WFI should produce water equivalent in quality to that produced by distillation. However, PDA has concerns with many of the approaches specified in this Q&A that are not science and risk based, some of which set requirements above and beyond what is in the Pharm. Eur. Monograph.
  • MHRA Data Integrity GxP Guideline Submitted 1 November 2016
    PDA proposes that the document should be clearly stated as being applicable to all GxP operations, and as the replacement of any earlier MHRA document on data integrity, to avoid any confusion.
  • EMA Sterilization Guidance Submitted 13 October 2016
    Based on the documented, successful, safe application of aseptic processing for many years, there is a lack of scientific and risk‐based evidence to support the need for application of terminal sterilization or other lethal treatment processes in well ‐designed, properly controlled and operated aseptic processes.
  • FDA Draft Guidance Insanitary Conditions at Compounding Facilities Submitted 3 October 2016
    PDA requests clarification on which products are in and out of scope and recommends products requiring sterile preparation such as ophthalmic products and wound care products are clearly included.
  • FDA Metrics Technical Conformance Guide Submitted 26 September 2016
    PDA suggests FDA provide a pilot or “sandbox” where companies could make example submissions and receive FDA feedback on whether the response meets expectations. PDA further recommends FDA engage in collaborative dialogue on preparing the validation rules for these data sets rather than waiting to disclose the rules once finalized.
  • WHO Draft Guideline QAS 16.671 Appendix 4 Analytical Method Validation Submitted 23 August 2016
    PDA notes some of the terminology used in the document is not clear and seems inconsistent with other global standards . In addition PDA suggests adding a reference to ICH Q2 (R1) Validation of Analytical Procedures.
  • WHO Guidelines on Validation Submitted 23 August 2016
    PDA recommends the inclusion of examples of ICH practices that will further the efforts to harmonize guidelines worldwide. We also note that use of the term “all” within the document can be interpreted as fully inclusive, which may not be the intention for every instance. PDA also recommends reconsideration of using example/forms, as they too may be prescriptive for those referencing this guidance for their validation practices. We have provided specific examples within the comment matrix for each.
  • WHO Draft Guideline QAS 16.666 Validation Submitted 18 July 2016
    PDA notes some terms and acronyms that could be used and defined more consistently with international standards. Also this guideline does not discuss packaging validation which is different from similar guidelines such as Europe’s Annex 15 (2015) and PIC/S guide (2015).
  • FDA Draft AMD for Immunogenicity Testing Submitted 6 July 2016
    The updated version of this guidance document provides useful clarifications of strategies provided in the original 2009 guidance based on increased experiences with immunogenicity assays, and includes twice as many key literature references. PDA recognizes this draft adds information regarding immunogenicity assays for combination products and ADC’s; points to information regarding immunogenicity assays for biosimilar products; and utilizes the current FDA terminology. It also clarifies the relationship of this guidance to animal immunogenicity assays and points to relevant guidance documents for those.
  • FDA Draft Guidance Comparability Protocols Submitted 30 June 2016
    PDA encourages FDA to work towards alignment of this guidance and the ICH Q12 document. In addition PDA recommends that combination products should be included in this scope. Please also clarify if there are any special considerations for Comparability Protocols (CPs) for biosimilar products.
  • FDA Draft Guidance Data Integrity and Compliance with cGMP Submitted 19 June 2016
    PDA recommends the scope of this guidance be enlarged to represent the spectrum of issues seen in warning letters and has made some specific suggestions in the attached comments. PDA also recommends FDA add a question and answer explaining the concept of data lifecycle for additional clarity and has provided a suggestion.
  • FDA Draft Guidance Implementation of Deemed to be a License Provision of BPCIA (NDA to BLA Conversion) Submitted 23 May 2016
    PDA recommends that FDA explicitly state in this or future guidance its intent to consider the transition as an administrative process (as opposed to one that requires data or a substantive review). Biological products approved under section 505 of the FD&C Act are demonstrated to be safe and effective and have a long history of quality.
  • FDA Draft Guidance for Industry - Human Factors Studies and Related Clinical Study Considerations Submitted 4 May 2016
    In order to maximize clarity and avoid duplicate or conflicting information, PDA recommends that this new guidance be built upon the foundation of the CDRH Final Guidance Applying Human Factors and Usability Engineering to Optimize Medical Device Design and/or the IEC standard and only address the new issues and special consideration that would apply to Combination Products (CP). PDA also recommends that this guidance title be changed to “Human Factors Study Considerations in Combination Product Design and Development” Given the definitions of HF and clinical studies, PDA encourages the FDA to change the references throughout the document to eliminate any confusion. HF studies and clinical studies have different purposes.
  • USP General Chapters Prospectus Submitted 29 March 2016

    PDA appreciates that the USP has listened to the feedback of its stakeholders, and has put in place this General Chapter Prospectus pilot process for early input into general chapters.   This new process will enhance the knowledge base of the Expert Committees, and will hopefully result in chapters with broader industry consensus and buy-in.

    With respect specifically to the Prospectus on Storage and Transportation of Investigational Drug Products, PDA believes the creation of this general chapter is superfluous  and will cause confusion ultimately resulting in delay in bringing new therapies to the market.    Whereas PDA believes that in the case of the Prospectus on Metal Packaging Components and their Materials of Construction, this fits well within the primary remit of the USP, to develop monographs that ensure safe drugs and supports the development of this general chapter.

  • FDA eCTD Conformance Guide - Considerations for Combination Product Submissions 19 January 2016

    PDA believes this technical conformance guide has important new content expectations that will have a significant impact on industry, primarily those involved in combination product submissions. As such, PDA strongly believes that these expectations should have been issued in a Type 1 draft policy guidance and not as final. Publication in a final technical conformance guide, will not, and has not resulted in sufficient awareness among concerned parties. Thus, PDA believes FDA will not receive a full range of comments; which undermines the necessary public’s input on these topics. PDA also believes this substantive content is more appropriate for a draft policy guidance and not for publication or inclusion in a technical conformance guide. The confounding of policy and technical issues is a disservice to both industry and the FDA.

    PDA strongly encourages FDA to withdraw the sections of the eCTD conformance guide related to Combination Products and Human Factors and re-issue these in a Type 1 draft guidance. In addition, PDA offers the comments to those sections to be considered for the draft guidance.

  • EMA Draft Guideline on Manufacture of the Finished Dosage Form submitted 15 January 2016
    PDA comments are primarily for clarification as this new guideline replaces the previous note for guidance and does not introduce new requirements on authorized medicinal products. For example, PDA recommends that the scope and wording of the guideline should be precise in order to avoid any misinterpretation. The wording as chosen in the draft ("chemical and herbal medicinal products") does not include all medicinal products that are regulated by Dir 2001/83/EC, e.g. drug products containing semi-synthetic active substances or immunological medicinal products are not explicitly listed; it is therefore not clear, on whether the guidance applies to those drug products.