Department of Health and Human Services March 11, 2020 – Federal Register Recent Federal Regulation Documents
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Q3D(R1) Elemental Impurities; International Council for Harmonisation; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised final guidance for industry entitled ``Q3D(R1) Elemental Impurities.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This guidance finalizes the draft guidance ``Q3D(R1) Elemental Impurities'' published on July 13, 2018. This guidance revises the existing guidance for industry ``Q3D Elemental Impurities'' and provides an updated permitted daily exposure (PDE) for the cadmium inhalation route of exposure. The updated PDE of 3 micrograms ([micro]g)/day is based on a modifying factor approach like that used for calculating the PDEs for the cadmium oral and parenteral routes of exposure. This revised guidance is intended to correct a calculation error in the PDE for cadmium by the inhalation route of exposure.
Providing Regulatory Submissions in Alternate Electronic Format; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Alternate Electronic Format.'' Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Congress granted FDA the authority to implement the statutory electronic submission requirements in guidance. In response, FDA implemented binding guidance requiring that new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) be submitted to the Agency in electronic common technical document (eCTD) format. Recognizing that some submissions are exempt from this requirement and that waivers of the requirement may be granted on a case-by-case basis, the Agency is issuing this draft guidance to describe the alternate electronic format sponsors or applicants should use for submissions covered under such exemptions and waivers.
Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials.'' The meeting will be convened by Duke University's Robert J. Margolis, Center for Health Policy (Duke-Margolis) and supported by a cooperative agreement with FDA. The meeting is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development.
Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Reopening of the Comment Period
The Food and Drug Administration (FDA, Agency, or we) is reopening the comment period for the notice that appeared in the Federal Register of April 3, 2019, and extending it indefinitely. The notice announced a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. In addition, it notified the public that FDA was establishing a docket for public comment on this hearing and that the docket would close on July 2, 2019. On June 20, 2019, a notice that appeared in the Federal Register extended the comment period to July 16, 2019. To provide a public and transparent way for stakeholders to provide new and emerging information to us in real time as it becomes available, we are reopening the comment period and extending it indefinitely to allow interested parties to continue to comment. We are particularly interested in data that may help to address uncertainties and data gaps related to the safety of cannabidiol (CBD).
Request for Letters of Interest (LOI) for Pediatric Focused NCI-MATCH Laboratories
The National Cancer Institute (NCI) through its National Clinical Trials Network (NCTN) is developing a successor precision medicine trial to `NCI-Molecular Analysis for Therapy Choice (NCI- MATCH)' entitled `NCI-ComboMATCH'. The principal of this intiative is to overcome drug resistance to single-agent therapy by developing genomically-directed targeted agent combinations. All combinations must be supported by robust, preclinical in vivo evidence. NCI-ComboMATCH trial leadership invites applications for Clinical Laboratory Improvements Program (CLIA) certified/accredited laboratories that test tumor specimens from pediatric patients utilizing Next-Generation Sequencing (NGS) assays to participate in the NCI-ComboMATCH trial. In order to support this trial, the designated laboratories participating in NCI-ComboMATCH will identify pediatric patients for the specific variants needed for trial eligibility. Laboratories will be required to contact any of the NCTN sites that have activated NCI- ComboMATCH if a specimen sent from one of these sites has a variant(s) that would potentially make the patient eligible for one of the treatment arms.
Request for Letters of Interest (LOI) for NCI-MATCH Laboratories
The National Cancer Institute (NCI) through its National Clinical Trials Network (NCTN) is developing a successor precision medicine trial to `NCI-Molecular Analysis for Therapy Choice (NCI- MATCH)' entitled `NCI-ComboMATCH'. The principal of this intiative is to overcome drug resistance to single-agent therapy by developing genomically-directed targeted agent combinations. All combinations must be supported by robust, preclinical in vivo evidence. NCI-ComboMATCH trial leadership invites applications for Clinical Laboratory Improvements Program (CLIA) certified/accredited laboratories that test tumor specimens from patients utilizing Next- Generation Sequencing (NGS) assays to participate in the NCI-ComboMATCH trial. In order to support this trial, the designated laboratories participating in NCI-ComboMATCH will identify patients for the specific variants needed for trial eligibility. Laboratories will be required to contact any of the NCTN sites that have activated NCI-ComboMATCH if a specimen sent from one of these sites has a variant(s) that would potentially make the patient eligible for one of the treatment arms.
Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.8 With Standard for Exchange of Nonclinical Data Implementation Guide-Animal Rule Version 1.0
The Food and Drug Administration (FDA or Agency) Center for Drug Evaluation and Research (CDER) is announcing that FDA will begin supporting the Clinical Data Interchange Standards Consortium (CDISC) for Study Data Tabulation Model version 1.8 (SDTM v1.8), and CDISC Standard for Exchange of Nonclinical Data Implementation GuideAnimal Rule version 1.0 (SENDIG-AR v1.0) on March 15, 2020, and that these new standards will be required in submissions to FDA effective March 15, 2022. An update will be made to the FDA Data Standards Catalog (Catalog) to reflect these changes.
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