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The FDA has announced the Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality. This move is one critical component of the agency’s initiative to modernize the New Drugs Regulatory Program. The FDA expects these changes to not only enable greater efficiency, but to also better understand the diseases intended to be treated by the drugs being evaluated for approval. The OND will also create cross-functional support offices of New Drug Policy, Drug Evaluation Sciences, Regulatory Operations, Operations, and Administrative Operations.

On 9 September 2019, the FDA published the Acceptance Review for De Novo Classification Requests

Final Guidance Document. The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic class III designation (De Novo classification request or De Novo request) meets a minimum threshold of acceptability and should be accepted for substantive review. The guidance includes 2 appendices similar in form to a ‘check list’. Appendix A includes information regarding the acceptance criteria which will ensure the DeNovo classification request includes sufficient information for substantive review. This checklist will determine whether the request is accepted or whether an RTA will be issued. Appendix B is a recommended content checklist. The FDA is observing a 60-day transition period between 8 September – 7 November, 2019 during which applications will be accepted per existing process. RTA reviews will begin on 8 November 2019. Please see the guidance document for further information.

The FDA committed to developing “electronic submission templates that will serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process” and “[by] FY [fiscal year] 2020, the Agency will issue a draft guidance document on the use of the electronic submission templates.” Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act

Draft Guidance Document, is intended to satisfy the draft guidance documents referenced in section 745A(b)(3) and the MDUFA IV Commitment Letter. This draft guidance is not final nor is it in effect at this time. The agency has concluded that it is not feasible to provide and implement an electronic format that would apply to all submissions covered by section 745A(b) of the FD&C Act in one guidance document. Therefore, the published draft document describes the FDA’s plan to develop individual guidances specific to submission type with corresponding timetables for implementation, as well as criteria for waivers of and exemptions from the requirements.

With FDA’s commitment to facilitate generic drug product availability and to assist the generic pharmaceutical industry with development, 53 Product-Specific Guidances for Generic Drug Development have recently been published. Of these guidances – 34 are new and 19 are revised. Five of the new draft guidances and 11 of the revised draft guidances are for complex drug products. Nearly half of these 53 PSGs (8 complex and 18 non-complex) are for products with no approved Abbreviated New Drug Application (ANDA).

On 20 September 2019, the FDA announced limits on packaging for the anti-diarrhea medicine loperamide (Imodium) to encourage safe use. This link will bring you to the agency’s webpage where you may find more information on the FDA’s approved changes to the packaging.

Guidance Document updates on the FDA website

ALL DIVISIONS

Clinical Decision Support Software

The Food and Drug Administration (FDA) has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including software that is intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of diseases or other conditions (often referred to as clinical decision support software). This guidance provides clarity on the scope of FDA’s oversight of clinical decision support software intended for health care professionals, patients, or caregivers.

CDER

Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act

This draft guidance updates the November 2014 guidance to account for recent regulatory changes and describes a change in FDA’s current thinking on what constitutes a 505(q) petition. In addition, FDA is revising this guidance to describe some of the considerations FDA will take into account in determining whether a petition is submitted with the primary purpose of delaying the approval of an application.

Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older

This guidance provides recommendations to sponsors on the clinical development of drugs for the treatment of partial onset seizures (POS) in pediatric patients.

Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Q & A

This guidance provides recommendations to sponsors, applicants, and contract research organizations regarding internal standard (IS) response variability in chromatographic analytical data submitted in investigational new drug applications, new drug applications, abbreviated new drug applications, biologics license applications, and supplements.

CDER & CBER

Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment

The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological products for the treatment of amyotrophic lateral sclerosis (ALS).

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy

This guidance is intended for wholesale distributors who must verify the product identifier upon receipt of a returned product that the wholesale distributor intends to further distribute as required under section 582(c)(4)(D) of the Federal Food, Drug, and Cosmetic Act.

Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products

This document provides guidance to sponsors and applicants on interacting with the FDA on complex innovative trial design (CID) proposals for drugs or biological products. FDA is issuing this guidance to satisfy, in part, a mandate under section 3021 of the 21st Century Cures Act (Cures Act).

Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products

This guidance provides recommendations to industry about the use of placebos and blinding in randomized controlled clinical trials in development programs for drug or biological products to treat hematologic malignancies and oncologic diseases.

CDRH & CBER

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act

Section 3060(a) of the 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on December 13, 2016, removing certain software functions from the definition of device in section 201(h) of the FD&C Act. This guidance provides FDA’s current thinking regarding the amended device definition and the resulting effect the amended definition has on FDA’s guidances related to medical device software.

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

FDA’s current thinking on the definition of MDDS is reflected in this guidance.

Policy for Device Software Functions and Mobile Medical Applications

The FDA is issuing this guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”) or on general-purpose computing platforms.

The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

In accordance with amendments made to section 514 by the FDA Reauthorization Act of 2017 (FDARA), and as part of the enactment of the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA was directed to issue a draft guidance regarding the goals and implementation of the ASCA Pilot. This draft guidance refers to voluntary consensus standards.

Safety and Performance Based Pathway

This guidance provides FDA’s current thinking on expanding the concept of the Abbreviated 510(k) Program for demonstrating substantial equivalence for premarket notification (510(k)) submissions.

Safer Technologies Program for Medical Devices

The FDA is introducing a new, voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program. Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classification request (“De Novo request”), or premarket notification (510(k)).

Format for Traditional and Abbreviated 510(k)s

The main focus of this document is to provide guidance on how to format an original submission for a Traditional or Abbreviated premarket notification (510(k)) submission.

The Abbreviated 510(k) Program

This guidance provides recommendations on an optional approach that may be used to demonstrate substantial equivalence in premarket notifications (510(k)s).

The Special 510(k) Program

This guidance provides the Food and Drug Administration’s (FDA) current thinking on premarket notifications (510(k)s) appropriate for review as a Special 510(k).

Refuse to Accept Policy for 510(k)s

The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a premarket notification (510(k)) submission meets a minimum threshold of acceptability and should be accepted for substantive review.

FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals

Performance goals were negotiated and agreed to under MDUFA IV for De Novo requests received in FY 2018-2022. These performance goals and process improvements are outlined in the MDUFA IV Commitment Letter from the Secretary of Health and Human Services (the Secretary) to Congress and are further described in the document.

User Fees and Refunds for De Novo Classification Requests

The purpose of this guidance document is to identify: 1) the types of De Novo requests subject to user fees; 2) exceptions to user fees; and 3) the actions that may result in refunds of user fees that have been paid. This document incorporates the impact of process improvements from MDUFA IV.

Humanitarian Device Exemption (HDE) Program

FDA developed this guidance document to provide clarity to industry and FDA staff about the current review practices for the Humanitarian Device Exemption (HDE) Program.

Humanitarian Use Device (HUD) Designations

This guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD) designation requests to the U.S. Food and Drug Administration’s (FDA or Agency) Office of Orphan Products Development (OOPD).

Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications

FDA has developed this guidance document to provide greater clarity for FDA reviewers and industry regarding the principal factors FDA considers when making benefit-risk determinations during the premarket review process for certain medical devices.

Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations

This draft guidance is intended to: 1) help sponsors understand how they can use patient engagement to elicit experience, perspectives, and other relevant information from patient advisors (see definition in Section IV) to improve the design and conduct of medical device clinical investigations; 2) highlight the benefits of engaging with patient advisors early in the medical device development process; 3) illustrate which patient engagement activities are generally not considered by FDA to constitute research or an activity subject to FDA’s regulations, including regulations regarding institutional review boards (IRBs); and 4) address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical investigation.

CDRH

General Wellness: Policy for Low Risk Devices

The Food and Drug Administration (FDA) is issuing this guidance document to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health’s (CDRH’s) compliance policy for low risk products that promote a healthy lifestyle (general wellness products). This guidance does not apply to products (e.g., drugs, biologics, dietary supplements, foods, or cosmetics) regulated by other FDA Centers or to combination products.

Off-The-Shelf Software Use in Medical Devices

This guidance document was developed to address the many questions asked by medical device manufacturers regarding what they need to provide in a premarket submission to the FDA when they use OTS Software.

Conventional Foley Catheters – Performance Criteria for Safety and Performance Based Pathway

This draft guidance provides performance criteria for conventional Foley catheters in support of the Safety and Performance Based Pathway.

Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway

This draft guidance provides performance criteria for cutaneous electrodes in support of the Safety and Performance Based Pathway.

Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway

This draft guidance provides performance criteria for non-spinal metallic bone screws and their associated washers in support of the Safety and Performance Based Pathway.

Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway

This draft guidance provides performance criteria for spinal plating systems in support of the Safety and Performance Based Pathway.

Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions

This guidance document describes the Food and Drug Administration’s (FDA or Agency) current approach to considering uncertainty in making benefit-risk determinations to support FDA premarket decisions for medical device premarket approval applications (PMAs), De Novo requests, and humanitarian device exemption (HDE) applications.

CVM

#171 Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products or Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media

This document describes how the Center for Veterinary Medicine (CVM) intends to evaluate requests for waiving the requirement for performing in vivo bioequivalence studies (biowaivers) for animal drugs administered orally as soluble powders or as Type A medicated articles manufactured from active pharmaceutical ingredients (APIs) considered to be soluble in aqueous media (water soluble APIs).

#261 Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs

This guidance is intended for sponsors and potential sponsors interested in pursuing conditional approval of new animal drugs for certain major uses in major species.

#263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter

This guidance is intended for sponsors of approved applications and abbreviated applications for new animal drugs containing medically important antimicrobials for use in non-food (companion), food-producing animals, or both, that are currently approved with over-the-counter marketing status.

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