Development of Best Practices in Physiologically Based Pharmacokinetic Modeling To Support Clinical Pharmacology Regulatory Decision-Making; Public Workshop, 27136-27137 [2019-12256]

Download as PDF khammond on DSKBBV9HB2PROD with NOTICES 27136 Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices In a letter dated August 25, 2004, Johnson & Johnson Pharmaceutical Research and Development, LLC requested withdrawal of NDA 019084 for NIZORAL (ketoconazole) topical cream, 2%. In the Federal Register of November 7, 2007 (72 FR 62858), FDA announced that it was withdrawing approval of NDA 019084, effective December 7, 2007. Arent Fox LLP submitted a citizen petition dated December 19, 2018 (Docket No. FDA–2018–P–4812), under 21 CFR 10.30, requesting that the Agency determine whether NIZORAL (ketoconazole) topical cream, 2%, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that NIZORAL (ketoconazole) topical cream, 2%, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that NIZORAL (ketoconazole) topical cream, 2%, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of NIZORAL (ketoconazole) topical cream, 2%, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list NIZORAL (ketoconazole) topical cream, 2%, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: June 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–12308 Filed 6–10–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:36 Jun 10, 2019 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–2039] Development of Best Practices in Physiologically Based Pharmacokinetic Modeling To Support Clinical Pharmacology Regulatory Decision-Making; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER), is announcing a public workshop entitled ‘‘Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-Making.’’ The purpose of this public workshop is to discuss best practices and evidentiary criteria in the use of physiologically based pharmacokinetic (PBPK) modeling approaches to support regulatory decision-making; share experiences and cases where applying PBPK modeling and simulation highlight the opportunities and limitations of this approach; obtain input from stakeholders on when, where, how, and with what limitations PBPK modeling and simulation may be applied in regulatory decision-making; and discuss the knowledge gaps and research needed to advance PBPK modeling sciences in drug development to support regulatory decisions. This public workshop is also being conducted to satisfy one of FDA’s performance goals included in the sixth reauthorization of the Prescription Drug User Fee Amendments (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA), to hold a series of workshops related to model-informed drug development (MIDD). DATES: The public workshop will be held on November 18, 2019, from 8 a.m. to 5 p.m., Eastern Time. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, B and C), Silver Spring, MD 20993–0002. Entrance for public workshop participants (non-FDA employees) is through Building 1 where routine security procedures will be SUMMARY: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 performed. For parking and security information, please refer to: https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. FOR FURTHER INFORMATION CONTACT: Lauren Milligan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3159, Silver Spring, MD 20993–0002, 240– 402–6421, email: Lauren.Brum@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Under FDARA, and in accordance with section I, part J of the PDUFA VI Performance Goals, FDA agreed to convene a series of workshops to identify best practices for MIDD (https:// www.fda.gov/downloads/ForIndustry/ UserFees/PrescriptionDrugUserFee/ UCM511438.pdf at 27). FDA is conducting this workshop as part of the MIDD workshop series. PBPK modeling is a drug development tool that mathematically integrates physiological, physicochemical, and drug-dependent preclinical and clinical information to predict an investigational drug’s absorption, distribution, metabolism, excretion, and pharmacokinetics (PK). Over the past several decades, there has been extensive research using PBPK modeling and simulation to address a wide range of clinical questions, such as exploring the effects of extrinsic factors (e.g., concomitant medications, food intake) and intrinsic factors (e.g., age, organ dysfunction, disease status, genetics) on drug exposures. FDA notes that PBPK modeling and simulation approaches are extensively used in regulatory submissions to predict the potential for drug-drug interactions and to support dosing recommendations for certain drugs when they are co-administered with metabolic enzyme modulators. However, challenges and knowledge gaps prevent PBPK modeling from being routinely used for specific regulatory decisions. Given the current limitations of the approach, it is important that the scientific community explore when, where, and how PBPK modeling and simulation may be applied in regulatory decision-making. II. Objectives The objectives of the workshop are to: 1. Discuss ‘‘best practices’’ in integrating in vitro and in vivo data to develop PBPK models and developing evidentiary criteria E:\FR\FM\11JNN1.SGM 11JNN1 Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices for PBPK models to be used for regulatory decision-making. 2. Share experiences and cases applying PBPK modeling and simulation that highlight the opportunities and limitations of this approach. 3. Obtain input from the stakeholders on when, where, how, and with what limitations PBPK modeling and simulation may be applied in regulatory decision-making. 4. Discuss the knowledge gaps and research needs to advance PBPK modeling sciences in drug development and regulatory evaluation. khammond on DSKBBV9HB2PROD with NOTICES A detailed agenda will be posted in advance of the workshop at https:// www.fda.gov/Drugs/NewsEvents/ ucm633778.htm. 17:36 Jun 10, 2019 Jkt 247001 Dated: June 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–12256 Filed 6–10–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration III. Participating in the Public Workshop Registration: Persons interested in attending this public workshop must register online by November 8, 2019, at https://www.eventbrite.com/e/pbpkmodeling-to-support-clinicalpharmacology-regulatory-decisionmaking-tickets-59005519096. Please provide complete contact information for each attendee. Registration is free and based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited. FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 8 a.m. If you need special accommodations due to a disability, please contact Lauren Milligan (see FOR FURTHER INFORMATION CONTACT) no later than November 8, 2019. Streaming Webcast of the Public Workshop: This public workshop will also be webcast. A live webcast of this workshop will be available at https:// www.fda.gov/Drugs/NewsEvents/ ucm633778.htm on the day of the workshop. If you have never attended a Connect Pro event before, test your connection at https:// collaboration.fda.gov/common/help/en/ support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.fda.gov/ Drugs/NewsEvents/ucm633778.htm. It may be viewed at the Dockets VerDate Sep<11>2014 Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A link to the transcript will be available on the internet at https://www.fda.gov/ Drugs/NewsEvents/ucm633778.htm. [Docket No. FDA–2018–E–0047] Determination of Regulatory Review Period for Purposes of Patent Extension; ALUNBRIG AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ALUNBRIG and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. SUMMARY: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by August 12, 2019. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 9, 2019. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 12, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery DATES: PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 27137 service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2018–E–0047 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; ALUNBRIG.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper E:\FR\FM\11JNN1.SGM 11JNN1

Agencies

[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Pages 27136-27137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12256]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2039]


Development of Best Practices in Physiologically Based 
Pharmacokinetic Modeling To Support Clinical Pharmacology Regulatory 
Decision-Making; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) Center for Drug 
Evaluation and Research (CDER), in collaboration with the Center for 
Biologics Evaluation and Research (CBER), is announcing a public 
workshop entitled ``Development of Best Practices in Physiologically 
Based Pharmacokinetic Modeling to Support Clinical Pharmacology 
Regulatory Decision-Making.'' The purpose of this public workshop is to 
discuss best practices and evidentiary criteria in the use of 
physiologically based pharmacokinetic (PBPK) modeling approaches to 
support regulatory decision-making; share experiences and cases where 
applying PBPK modeling and simulation highlight the opportunities and 
limitations of this approach; obtain input from stakeholders on when, 
where, how, and with what limitations PBPK modeling and simulation may 
be applied in regulatory decision-making; and discuss the knowledge 
gaps and research needed to advance PBPK modeling sciences in drug 
development to support regulatory decisions. This public workshop is 
also being conducted to satisfy one of FDA's performance goals included 
in the sixth reauthorization of the Prescription Drug User Fee 
Amendments (PDUFA VI), part of the FDA Reauthorization Act of 2017 
(FDARA), to hold a series of workshops related to model-informed drug 
development (MIDD).

DATES: The public workshop will be held on November 18, 2019, from 8 
a.m. to 5 p.m., Eastern Time. See the SUPPLEMENTARY INFORMATION section 
for registration date and information.

ADDRESSES: The public workshop will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503, B and C), Silver Spring, MD 20993-0002. Entrance for public 
workshop participants (non-FDA employees) is through Building 1 where 
routine security procedures will be performed. For parking and security 
information, please refer to: https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Lauren Milligan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3159, Silver Spring, MD 20993-0002, 240-
402-6421, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Under FDARA, and in accordance with section I, part J of the PDUFA 
VI Performance Goals, FDA agreed to convene a series of workshops to 
identify best practices for MIDD (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf at 27). FDA 
is conducting this workshop as part of the MIDD workshop series.
    PBPK modeling is a drug development tool that mathematically 
integrates physiological, physicochemical, and drug-dependent 
preclinical and clinical information to predict an investigational 
drug's absorption, distribution, metabolism, excretion, and 
pharmacokinetics (PK). Over the past several decades, there has been 
extensive research using PBPK modeling and simulation to address a wide 
range of clinical questions, such as exploring the effects of extrinsic 
factors (e.g., concomitant medications, food intake) and intrinsic 
factors (e.g., age, organ dysfunction, disease status, genetics) on 
drug exposures.
    FDA notes that PBPK modeling and simulation approaches are 
extensively used in regulatory submissions to predict the potential for 
drug-drug interactions and to support dosing recommendations for 
certain drugs when they are co-administered with metabolic enzyme 
modulators. However, challenges and knowledge gaps prevent PBPK 
modeling from being routinely used for specific regulatory decisions. 
Given the current limitations of the approach, it is important that the 
scientific community explore when, where, and how PBPK modeling and 
simulation may be applied in regulatory decision-making.

II. Objectives

    The objectives of the workshop are to:

    1. Discuss ``best practices'' in integrating in vitro and in 
vivo data to develop PBPK models and developing evidentiary criteria

[[Page 27137]]

for PBPK models to be used for regulatory decision-making.
    2. Share experiences and cases applying PBPK modeling and 
simulation that highlight the opportunities and limitations of this 
approach.
    3. Obtain input from the stakeholders on when, where, how, and 
with what limitations PBPK modeling and simulation may be applied in 
regulatory decision-making.
    4. Discuss the knowledge gaps and research needs to advance PBPK 
modeling sciences in drug development and regulatory evaluation.

    A detailed agenda will be posted in advance of the workshop at 
https://www.fda.gov/Drugs/NewsEvents/ucm633778.htm.

III. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop 
must register online by November 8, 2019, at https://www.eventbrite.com/e/pbpk-modeling-to-support-clinical-pharmacology-regulatory-decision-making-tickets-59005519096. Please provide complete 
contact information for each attendee.
    Registration is free and based on space availability, with priority 
given to early registrants. Early registration is recommended because 
seating is limited. FDA may limit the number of participants from each 
organization. Registrants will receive confirmation when they have been 
accepted. If time and space permit, onsite registration on the day of 
the public workshop will be provided beginning at 8 a.m.
    If you need special accommodations due to a disability, please 
contact Lauren Milligan (see FOR FURTHER INFORMATION CONTACT) no later 
than November 8, 2019.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast. A live webcast of this workshop will be available at 
https://www.fda.gov/Drugs/NewsEvents/ucm633778.htm on the day of the 
workshop. If you have never attended a Connect Pro event before, test 
your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro 
program, visit https://www.adobe.com/go/connectpro_overview. FDA has 
verified the website addresses in this document, as of the date this 
document publishes in the Federal Register, but websites are subject to 
change over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.fda.gov/Drugs/NewsEvents/ucm633778.htm. It may be viewed at the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852. A link to the transcript 
will be available on the internet at https://www.fda.gov/Drugs/NewsEvents/ucm633778.htm.

    Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12256 Filed 6-10-19; 8:45 am]
 BILLING CODE 4164-01-P

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