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FDA announces FY2021 OMUFA facility user fees in the Federal Register Vol 85, No 249.  These fees are effective 1 October 2020 through 30 September 2021.  Each facility required to pay the user fee will need to generate a user fee cover sheet via the FDA’s User Fee System.

For OMUFA purposes:

  • An OTC monograph drug is a nonprescription drug without an approved new drug application which is governed by the provisions of section 505G of the FD&C Act;
  • An OTC monograph drug facility is a foreign or domestic business or other entity that, in addition to meeting other criteria, is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug. The Agency refers to such facility as Monograph Drug Facility (MDF);
  • A contract manufacturing organization (CMO) facility is an OTC monograph drug facility where neither the owner nor any affiliate of the owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States

The MDF facility user fee is $14,060; the CMO facility user fee is $9,373.  Further information on facility fees can be found on the FDA website Over-The-Counter Monograph User Fee Program (OMUFA).  The FR notification and FDA website also includes detailed information on the OMOR (OTC Monograph Order Request) program. EAS is available for any questions or support you may need with this new regulatory requirement.

Recently published Guidance Documents

All Divisions

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.

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency.

CDER

Dry Eye: Developing Drugs for Treatment Guidance for Industry

This guidance is intended to provide recommendations to sponsors regarding eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and to foster greater efficiency in development programs for drugs for the treatment of dry eye.

Controlled Correspondence Related to Generic Drug Development Guidance for Industry

This guidance provides information regarding the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development. This guidance also describes the Agency’s process for providing communications related to such correspondence.

This guidance replaces the September 2015 guidance for industry Controlled Correspondence Related to Generic Drug Development.

Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications

This guidance describes the FDA’s recommendations regarding: (1) when clinical DDI studies with ARAs are needed; (2) the design of clinical DDI studies; (3) how to interpret study results; and (4) communicating findings in drug product labeling.

CDER & CBER

Providing Regulatory Submissions in Electronic Format –Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling

This guidance describes the format requirements for the electronic submission of the content of a risk evaluation and mitigation strategy document under section 745A(a) of the FD&C Act. This guidance describes how FDA will implement the requirements for the electronic submission of REMS documents as part of submissions under new drug applications, abbreviated new drug applications, and, in certain biologics license applications.

Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry

FDA is issuing this guidance to provide information pertaining to review timelines that FDA will use during the COVID-19 public health emergency for the following applicant responses to complete response letters when a facility assessment is necessary before FDA can take action on a marketing application:

  • Amendments to original and supplemental abbreviated new drug applications submitted to FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act.
  • Resubmissions of original and supplemental biologics license applications submitted to FDA under sections 351(a) and (k) of the Public Health Service Act. 2

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 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.  In accordance with the Cures Act mandate, this guidance discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, how sponsors may obtain feedback on technical issues related to modeling and simulation, and the types of quantitative and qualitative information that should be submitted for review.

Best Practices in Developing Proprietary Names for Human Prescription Drug Products

FDA is issuing this guidance to help sponsors of human prescription drug products develop proprietary names for those products. This guidance describes best practices to help minimize proprietary name-related medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act and its implementing regulations.  It also describes the framework FDA uses in evaluating proposed proprietary names that is also available to sponsors to use before submitting names for FDA review if they wish.

Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products

FDA is issuing this guidance to help sponsors of human nonprescription drug products develop proprietary names for those products. This guidance describes best practices to help minimize proprietary name-related medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act and its implementing regulations. It also describes the framework FDA uses in evaluating proposed proprietary names that is available to sponsors to use for nonprescription drug products before a product bearing that proprietary name is marketed.

CDRH

Product Labeling for Laparoscopic Power Morcellators

This guidance contains recommendations concerning the content and format for certain labeling information for laparoscopic power morcellators. The recommendations in this guidance reflect the state of the science and available technology regarding use of LPMs and are being made in light of scientific information that suggests that the use of these devices contributes to the dissemination and upstaging of an occult uterine malignancy in women undergoing laparoscopic gynecologic surgery for presumed fibroids.

Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway

This guidance provides performance criteria for magnetic resonance receive-only 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 receive-only coils will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

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

This guidance provides performance criteria for non-spinal metallic bone screws and their associated washers 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 non-spinal metallic bone screws and washers will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

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

This guidance provides performance criteria for spinal plating systems 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 spinal plating systems will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency

FDA is issuing this guidance to provide FDA’s enforcement policy regarding certain quality standards requirements under the Mammography Quality Standards Act of 1992 and also to provide general considerations to facilities that may have temporarily ceased performing mammography or that may be continuing to perform mammography while facing difficulty in complying with certain quality standards requirements during the public health emergency. The MQSA is part of United States Code Title 42 – Public Health and Welfare, and is implemented in FDA’s regulations at 21 CFR part 900.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

CDRH & CBER

Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices – Questions and Answers (Revised)

FDA is issuing this guidance to provide answers to frequently asked questions about regulatory and policy issues related to device development for the duration of the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

CBER

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion

FDA is issuing this guidance document to provide, blood collection establishments and transfusion services, with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion.

This guidance updates the final guidance of the same title dated September 2019. The September 2019 guidance finalized the draft guidance of the same title dated December 2018.

Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis

FDA is providing blood establishments that collect Whole Blood or blood components, including Source Plasma, with recommendations for screening and testing of donors and management of donations based on screening tests for syphilis. Syphilis is a relevant transfusion-transmitted infection (Title 21 Code of Federal Regulations (CFR) 630.3 (h)(1)(v)).  Licensed blood establishments must report the implementation of the recommendations contained in this guidance in accordance with 21 CFR 601.12.

This guidance updates the guidance of the same title dated September 2014.

COVID-19 specific FDA webpages

Personal Protective Equipment EUAs

Face Masks, Including Surgical Masks, and Respirators for COVID-19

Hand Sanitizers / COVID-19 webpage update

FDA updates on hand sanitizers consumers should not use

Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2

Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2

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