Blog http://biophia.com//blog.php CDER Updates March/April 2017 6/2/2017 1:43:19 PM
  • Director's Corner With Dr. Janet Woodcock:  Looking back on 2016 accomplishments and Moving Forward in 2017.
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    Update to Guidance

    Section I. Introduction

    • Paragraph added describing rationale for changing timetable for required master file submissions in eCTD from 24 months to 36 months.

    Section III.B. Timetable for Implementation of Electronic Submission Requirements

    ·         Updated to reflect that the requirement for master files to be filed electronically takes place 36 months after May 5, 2015.

    Example of timetable updated to reflect actual timetable for the implementation of the electronic submissions requirement.

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    CBER Updates March/April 2017 6/2/2017 1:41:18 PM
  • Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Zika Virus 
    Posted: 3/13/2017
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    The Food and Drug Administration (FDA) issued a final rule, Use of Symbols in Labeling, June 15, 2016, that became effective September 13, 2016. The final rule permits the use of symbols in all medical device labeling without adjacent explanatory text (referred to as "stand-alone symbols") if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. The final rule seeks to harmonize the U.S. device labeling requirements for symbols with international regulatory requirements.

    Below is a list of resources on the use of symbols in labeling:

    ·         Final Rule: Use of Symbols in Labeling

    ·         Frequently Asked Questions

    FDA Voice: Using Symbols to Convey Information in Medical Device Labeling

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    CDRH Updates - March/April 2017 6/2/2017 1:38:02 PM
  • Presentation and Transcript added to Webinar - Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance - February 23, 2017
  • ·         Presentation (WMV - 11.4MB)

    ·         Printable Slides (PDF - 273KB)

    ·         Transcript (PDF - 155KB)

    §  Presentation (WMV - 19.5MB)

    §  Printable Slides (PDF - 937KB)

    §  Transcript (PDF - 274KB)

    §  Case Study: Using the De Novo Process to Classify and Bring to Market an Innovative, Low-to-Moderate Risk Device (PDF - 504KB)

     

    SUMMARY: The Food and Drug Administration (FDA or Agency) has  identified a list of class II devices that, when finalized, will be  exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment. Submit either electronic or written comments on the notice by May 15, 2017. 

     

    SUMMARY: The Food and Drug Administration (FDA or Agency) has  identified a list of class I devices that are now exempt from premarket  notification requirements, subject to certain limitations. FDA is  publishing this notice of that determination in accordance with  procedures established by the 21st Century Cures Act.
     


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    CDER Summary February 2017 3/3/2017 9:51:16 AM
  • CDER Small Business and Industry Education Series: Best Practices for Communication Between FDA and IND Sponsors During Drug Development 
    The course describes best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development. 


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    CBER Updates January 2017 2/17/2017 2:41:52 PM Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry (PDF - 99KB)

    We, FDA, are notifying you, blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, that we have determined Ebola virus to be a transfusion-transmitted infection (TTI) under Title 21 of the Code of Federal Regulations (CFR) 630.3(l). We are also providing you with recommendations for assessing blood donor eligibility, donor deferral and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission occurs in at least one country.

     

    Guidance Agenda: Guidance DocumentsCBER is Planning to Publish During Calendar Year 2017 (PDF - 25KB)

    This is the list of guidance topics CBER is considering for development during Calendar Year 2017. The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued Level 1 drafts that may be finalized following review of public comments. We currently intend to develop guidance documents on these topics; however, the Center is neither bound by this list of topics, nor required to issue every guidance document on this list. We are not precluded from developing guidance documents on topics not on this list. This list includes guidance documents CBER issued since the August 2016 Guidance Agenda update.

     

    Regenerative Advanced Therapy Designation

    As described in Section 3033 of the 21st Century Cures Act, a drug is eligible for designation as a regenerative advanced therapy (RAT) if:

    a.      The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations;

    b.      The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and

    c.       Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition

     

    Final Agenda: Public Workshop: Identification and Characterization of Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products (PDF - 214KB)

    Public Workshop: Identification and Characterization of Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products February 8-9, 2017

     



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    CDER Summary January 2017 2/17/2017 2:06:49 PM

     

    ·         Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017 (PDF- 40KB)

     

    ·         Guidance for Industry 180-Day Exclusivity: Questions and Answers (PDF - 240KB) Draft Guidance

    This guidance is intended to address questions that have been raised about the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that relate to generic drug exclusivity, which commonly is known as 180-day exclusivity for generic drug products.

     

    ·         Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application Guidance for Industry (PDF - 969KB) Draft Guidance

     

    ·         Nonproprietary Naming of Biological Products Guidance for Industry (PDF - 115KB)

    This guidance describes FDA’s current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix.

     

    ·         Multiple Endpoints in Clinical Trials (PDF - 687KB) Draft Guidance.

    This guidance provides sponsors and review staff with the Agency’s thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products.
     

    ·         Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (PDF - 200KB) Draft Guidance

    This guidance is intended to assist potential applicants who plan to develop and submit an 18 abbreviated new drug application (ANDA) to seek approval of a proposed combination product that includes both a drug constituent part and a delivery device constituent part.  The recommendations included in this guidance generally focus on the analysis of the proposed user interface for the generic drug-device combination product (generic combination product) when  compared to the user interface for the reference listed drug (RLD). For the purposes of this  guidance, the term user interface refers to all components of the combination product with which a user interacts. This includes the delivery device constituent part of the combination product and any associated controls and displays, as well as product labeling and packaging.

     

    ·         Referencing Approved Drug Products in ANDA Submissions Guidance for Industry (PDF - 155KB) Draft Guidance.

    This guidance is intended to provide information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission in an abbreviated new drug application (ANDA) submission.

     

    ·       From our perspective: Interchangeable biological products

     

     

    ·         Assessment of Abuse Potential of Drugs Guidance for Industry (PDF - 285KB)

    This guidance is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their new drug product has abuse potential. This guidance also provides recommendations to applicants who intend to submit new drug applications (NDAs) for prescription drug products that may have abuse potential.

     

    ·         Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry (PDF - 229KB) Draft Guidance

    This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under section 351(k) of the Public Health Service Act (PHS Act) (42 20 U.S.C. 262(k)).

     

    ·         Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers Guidance for Industry (PDF - 134KB) Draft Guidance.

    This guidance provides information for firms about how FDA evaluates firms’ medical product communications, including promotional materials, that present information that is not contained  in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product.

     

    ·         Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers Guidance for Industry and Review Staff (PDF - 609KB) Draft Guidance.

    This guidance provides answers to common questions regarding firms’ communication of health care economic information (HCEI) regarding their prescription drugs to payors, formulary  committees, or other similar entities with knowledge and expertise in the area of health care  economic analysis (collectively referred to as payors). This guidance also addresses common questions relating to dissemination of information about investigational drugs and devices (medical products ) to payors before FDA approval or clearance of such products.

     

    ·         FDA introduces reference standard data updates to the Orange Book

    On January 25, 2017, the FDA introduced an important data update to Approved Drug Products with Therapeutic Equivalence Evaluations – known as the “Orange Book.” Search results and drug listings now clarify which listed drugs are reference listed drugs (RLDs) and which are reference standards. Listings also indicate which products in the Discontinued Section may be referred to as an RLD. The FDA made these modifications to reflect recent clarifications published in the draft guidance for industry “Referencing Approved Drug Products in ANDA Submissions.” The print edition of the Orange Book also reflects these updates. The Orange Book mobile app will be updated to reflect these changes in the near future.

     

    ·         Data Standards in the Drug Lifecycle—updates include the Interactive “Data Standards in the Drug Lifecycle” Infographic

     

    ·         Registration Now Open: FDA and USP Workshop on Standards for Pharmaceutical Products FDA and USP Workshop on Standards for Pharmaceutical Products - Critical Importance of Excipients in Product Development – Why Excipients are Important Now and In the Future (February 27 - 28, 2017)

     

    Note: Comments and suggestions regarding  draft documents should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

     



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    CDRH Updates - January 2017 2/9/2017 9:56:28 AM  

    Federal Register: Medical Device Accessories--Describing Accessories and Classification Pathway for New Accessory Types; Guidance for Industry and Food and Drug Administration Staff; Availability

    SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Medical Device Accessories--Describing Accessories and Classification Pathways for New Accessory Types.'' This document provides guidance to industry and FDA staff about the regulation of accessories to medical devices. The guidance explains what devices FDA generally considers an ``accessory'' and encourages use of the de novo classification process under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to allow manufacturers and other parties to request risk- and regulatory control-based classification of accessories of a new type (i.e., accessories of a type that has not been previously classified under the FD&C Act, cleared for marketing under a 510(k) submission, or approved in an application for premarket approval (PMA)).

     

     

     

    Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff

    The purpose of this guidance is to provide greater clarity for FDA staff and investigational device exemption (IDE) sponsors and sponsor-investigators regarding the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human clinical studies.

    Another important goal of this guidance is to characterize benefits in the context of investigational research, which includes direct benefits to the subject and benefits to others (to the extent there are indirect benefits to subjects such as knowledge to be gained from the study or information that may contribute to developing a treatment).

    Document issued on January 13, 2017. This guidance will have a 60 day implementation period.

     

    Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities - Questions and Answers Draft Guidance

    SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing

    the availability of a draft guidance for industry and review staff entitled ``Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers.'' This draft guidance provides answers to common questions regarding the communication of health care economic information (HCEI) about approved prescription drugs by medical product manufacturers, packers, distributers, and their representatives (firms) to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis (collectively referred to as payors). This draft guidance also provides answers to common questions about firms' communications regarding investigational drugs and devices (investigational products) to payors before FDA approval or clearance of such products. The Agency is issuing this draft guidance to explain FDA's current thinking on frequently asked questions regarding such communications in order to provide clarity for firms and payors.

    Submit either electronic or written comments on the draft guidance by April 19, 2017.

     

    Medical Product Communications that are Consistent with the FDA-required Labeling - Questions and Answers Draft Guidance

    SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Medical Product Communications That Are Consistent With the FDA-Required Labeling--Questions and Answers.'' This draft guidance provides information for manufacturers, packers, and distributors and their representatives (collectively ``firms'') of drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs (collectively ``medical products''), about how FDA evaluates their medical product communications, including their promotional materials, that present information that is not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product. The Agency is issuing this draft guidance to explain FDA's current thinking on commonly asked questions regarding such communications in order to provide clarity for firms.

     

    Submit either electronic or written comments on the draft guidance by April 19, 2017.

     

     

    Federal Register: Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Availability of Memorandum; Reopening of the Comment Period

    SUMMARY: The Food and Drug Administration (FDA) is reopening the comment period for the notification of public hearing, published in the Federal Register of September 1, 2016 (81 FR 60299) concerning our comprehensive review of our regulations and policies governing manufacturer communications regarding unapproved uses of approved or cleared medical products. FDA is also announcing that it has added a document to the docket for the public hearing entitled ``Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products'' (Memorandum). The Memorandum provides additional background on the issues FDA is considering as part of its comprehensive review, including a discussion of First Amendment considerations. In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of two draft guidance for industry that address manufacturer communications, one entitled ``Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers,'' and the other entitled ``Medical Product Communications That Are Consistent With the FDA-Required Labeling--Questions and Answers.'' FDA is reopening the comment period to provide the public an opportunity to review the Memorandum as it relates to the specific questions and issues identified in the notification of public hearing as well as review the two draft guidances and provide additional or new comments.

     

    DATES: Submit either electronic or written comments by April 19, 2017.

     

    Presentation and Transcript posted for Webinar - Postmarket Management of Cybersecurity in Medical Devices Final Guidance - January 12, 2017



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    Biopharmaceutical Method Transfer 11/30/2016 5:48:17 PM Analytical method transfer in the biopharmaceutical industry has become a significant issue as more companies attempt/plan transfers to more locations across the world.  The challenges encountered in addressing technical and regulatory requirements for method transfer will be explored during the CASSS CMC Forum “Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry”   January 23, 2017 in Washington DC that I’m fortunate enough to co-chair (http://www.casss.org/page/CMCJ1700).   This meeting will include presentations by regulators (FDA and Health Canada) as well as industry leaders.  These meetings emphasize lively discussions and are always attended by a large number of regulators and industry leaders, providing a great opportunity to understand the most current thinking for industry and regulators!

    Struggles with method transfer include technical issues as well as unclear regulator expectations.  Frequently, individual companies are executing their own strategies after struggling with FDA suggestions to test for equivalency using a 2-sided student t testing with very tight criteria.  Currently there is no consensus approach to when formal method transfer is required or what approach should be used.  In some cases businesses have reduced/eliminated transfer plans.   Some companies are taking on increased risk by submitting their own strategy in post-transfer submissions after not being able to reach agreement with regulators on their strategy in advance.

    I’m presenting at the CASSS CMC Forum on a risk-based approach to method transfer consistent with both ICH and FDA guidances for method transfer. A risk-based approach can address transfer-related changes that can impact quality (e.g., passing results on material that should fail) as well as business concerns (e.g., failing material that should pass).  This flexible approach reduces the burden of transferring well-controlled methods as well as identifying problematic methods where more care is required in transferring methods.   Slides from a June 2016 talk are located at: http://c.ymcdn.com/sites/www.casss.org/resource/resmgr/MWDG/2016_MWDG_StaeckerJeff.pdf.

    The upcoming CMC Forum is followed by the 3-day Well Characterized Biologic Proteins meeting in the same location where Ed Moore and I can be visited at the BioPhia booth.  I look forward to seeing you at the upcoming CMC Forum in Washington DC or hearing from you directly regarding questions about method transfer!

     

    Jeff Staecker, Ph.D.

    Principal Consultant, BioPhia Consulting


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    Biopnia Now on LinkedIn 9/29/2016 4:53:42 PM We are excited to broadcast the unique capabilities of the BioPhia Consulting Company. BioPhia is a biotechnology, pharmaceutical and medical device consulting company dedicated to providing a wide array of critical scientific expertise focused on assisting clients in the discovery, development and commercialization of novel therapies. The company core represents over 100 years of industrial experience including broad expertise in chemistry, biochemistry, cell and molecular biology, immunology, disease pathogenesis, and broad based product development, scale-up and technology transfer. Accomplishments range from early stage discovery of innovative therapeutics to life cycle management of commercial products, with everything in between. Biophia strives to provide you our customer with real world, practical solutions, creative insight and timely, cost-competitive advice that will make a positive difference in their projects, products and performance.

     

    Please follow us on our newly created company page within LinkedIn https://www.linkedin.com/company/biophia-consulting-inc?trk=top_nav_home. Also we would highly appreciate it if you could recommend our company to your contacts.

     

    Let us help you solve your problems, to more rapidly and successfully move your products to the patients who require them.

     



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    Toxicology Risk Assessment 6/7/2016 10:11:26 AM Are you challenged with a Toxicology Risk Assessment?  BioPhia Consulting can help!

    BioPhia offers toxicological risk assessment (TRA) services for products manufactured and sold in a wide range of industries including pharmaceuticals, medical devices and container systems.

    Our toxicological risk assessments are tailored for each product based on its intended use and are designed to be applicable under all globally-relevant standards. BioPhia can also design appropriate strategies (e.g. toxicity testing, material biocompatibility testing, etc.) and oversee testing conducted at 3rd party laboratories on behalf of our clients.

    We assist our clients by guiding them to the most appropriate assessments and tests, helping to mitigate risk early in the process, reducing development time due to safety-related issues, and expediting product approval.

    BioPhia’s toxicologic services include:



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    CBER proposed publication 2016 5/3/2016 3:19:12 PM
    Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2016

    This list is only a proposal but it does provide some information about areas that the FDA is currently reviewing.
    This list includes documents in two general area: Blood and Blood Components (6 documents) and Cellular Tissue and Gene Therapy (3 documents) There are also two proposed documents in the “Other” category (2 documents).
    Most of the documents will be issued as draft guidances, but three will be final guidances. They are:
    • Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Final Guidance for Industry2 (published)
    • Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271; Final Guidance for Industry
    • Early Clinical Trials with Live Biotherapeutic Products:  Chemistry, Manufacturing, and Control Information; Final Guidance for Industry



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