December 2019 Drug and Device Corner

Guidance Document updates on the FDA website

All divisions

Certificates of Confidentiality (distributed for comment purposes only) – This draft guidance describes FDA implementation of the revised provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) (Public Law 114-255) amended the Public Health Service Act (PHS Act), section 301(d) (42 U.S.C. 241(d)) relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom identifiable, sensitive information is being collected or used in furtherance of the research.
Bridging for Drug-Device and Biologic-Device Combination Products – This guidance provides recommendations to industry and FDA staff on how to approach bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug-device and biologic-device single entity or copackaged combination products.
Requesting FDA Feedback on Combination Products – The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics.

CDER

Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products – The purpose of this guidance is to provide recommendations to applicants regarding whether and when comparative clinical immunogenicity studies may be needed to support licensure of proposed biosimilar and interchangeable recombinant human insulins, recombinant human insulin mix products, and recombinant insulin analog products that are intended for the treatment of patients with Type 1 or Type 2 diabetes mellitus (collectively described as “insulin products”).
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment – This guidance provides recommendations for establishing effectiveness for drugs intended to treat patients with interstitial cystitis/bladder pain syndrome (IC/BPS).
Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids – The purpose of this guidance is to assist sponsors in the clinical development of locally applied corticosteroid products (including suppositories or products that require an applicator) for the short-term treatment of symptoms associated with internal or external hemorrhoids. Specifically, this guidance describes FDA’s current thinking regarding the recommended attributes of patients for enrollment, efficacy assessments, and safety assessments.

CDER & CBER

Adaptive Designs for Clinical Trials of Drugs and Biologics – This document provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic.
FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act – The purpose of this guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards with information to facilitate pediatric studies of molecularly targeted oncology drugs.
Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff – Once finalized, this guidance will represent the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current thinking on taxonomy for biomarkers and other DDTs, and on implementation of section 507 of the FD&C Act with respect to the processes for requestors interested in qualifying DDTs.
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products – This document is intended to provide guidance to applicants planning to file new drug applications (NDAs), biologics license applications (BLAs), or applications for supplemental indications on the evidence to be provided to demonstrate effectiveness.
Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act – This guidance describes recommended procedures to obtain an additional National Drug Code (NDC) for an FDA-approved prescription drug that is imported into the United States in compliance with section 801 of the Federal Food, Drug, and Cosmetic Act. This guidance specifically addresses the importation of FDA-approved drugs that were also authorized for sale in a foreign country in which the drugs were originally intended to be marketed.

CDRH

Magnetic Resonance (MR) Coil – Performance Criteria for Safety and Performance Based Pathway – This draft guidance provides performance criteria for magnetic resonance (MR) coils in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for MR coils will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

CDRH & CBER

Real-Time Premarket Approval Application (PMA) Supplements – This guidance provides information about the real-time review process for premarket approval application (PMA) supplements and outlines the procedures for requesting and submitting these types of documents.
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act – The purpose of this guidance is to establish procedures for submitting, reviewing and responding to requests for information regarding the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug, and Cosmetic Act that are submitted in accordance with section 513(g) of the FD&C Act
eCopy Program for Medical Device Submissions – This is an updated version of the guidance that was issued on October 10, 2013. It provides clarification to the processing and technical standards for eCopies based on FDA’s experience to date with the program.
Annual Reports for Approved Premarket Approval Applications (PMA) – This guidance document describes the information required to be submitted in annual reports under 21 CFR 814.84(b), additional information requirements that may be imposed by approval order under 21 CFR 814.82(a), and FDA’s recommendations for the level of detail the applicant should provide in the annual report.
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) – This guidance is intended to be used by FDA staff and the device industry to help elucidate the broad preclinical and clinical issues that need to be addressed in a PMA and the key decisions to be made during the filing process.
30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes – This document replaces the guidance entitled, “30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes,” issued February 19, 1998. This new guidance includes updates to reflect the current review process, additional examples of manufacturing changes that may be submitted under this program, and a discussion of user fees.
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions – The Food and Drug Administration (FDA) has developed this document to describe relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests).

CBER

COMPLIANCE POLICY GUIDE (CPG) Chapter 2 – Biologics – Submit comments on this guidance document electronically via docket ID:FDA-2013-S-0610– Specific Electronic Submissions Intended For FDA’s Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
Considerations for the Development of Dried Plasma Products Intended for Transfusion – This guidance provides considerations for the successful development and licensing of dried plasma products and for the approval of devices used to manufacture dried plasma.
Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review – This technical specifications document provides you, sponsor/applicant detailed information and specifications for the content of datasets submitted to FDA’s Center for Biologics Evaluation and Research (CBER) Office of Vaccines Research and Review (OVRR) and is designed to aid clinical and statistical reviewers in the review of vaccine applications, e.g., biologics license applications.

Posted in Drug and Device Corner, Drugs, Medical Devices.