FDA Regulatory News and Trends - November 7, 2023
Welcome to FDA Regulatory News and Trends, designed to help you identify significant legal developments and navigate the evolving business, legal, and regulatory world.
CBER releases guidance on the use of standards for regenerative medicine therapies.
- On October 19, 2023, Center for Biologics Evaluation and Research (CBER) published a guidance document titled, “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” This final guidance describes the center's implementation of a new program for recognition of certain Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products.
- RMTs include cell therapies, therapeutic tissue engineering products, and human cell and tissue products, as well as combination products using these therapies or products. The center explains that the use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for these products.
- In order for a VCS to be recognized by this program, it must have been developed in a way that adheres with five elements: (1) Openness, (2) Balance, (3) Due Process, (4) Appeals Process, and (5) Consensus.
- Companies developing RMT products are encouraged to monitor FDA's Regenerative Medicine website where CBER plans to post recognized VCS and consider adopting them. While use of the standards recognized by this program is not required, CBER’s recognition of a VCS communicates to FDA staff and external stakeholders that FDA has found it appropriate for the development and review of RMT products.
CDRH releases two guidances related to magnetic resonance devices.
- On October 10, 2023, the Center for Devices and Radiological Health (CDRH) published two guidance documents superseding earlier guidance related to magnetic resonance (MR) devices and the use of other medical devices in MR environments.
- The first guidance, titled, “Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices,” elaborates on CDRH's expectations for information that should be included in premarket notification submissions for MR devices. The recent update reflects a change in the FDA-recognized international standard IEC 60601-2-33, which loosens the static magnetic field level considered to cause harm from 0.5 mT to 0.9 mT.
- The second guidance, titled, “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment,” describes expectations for safety testing of medical devices used in an MR environment and provides recommendations on label content for these devices. Like the first guidance, this revision references the new IEC standard.
- Manufacturers planning 510(k) submissions for an MR device, or performing testing for a device to be used in an MR environment, are encouraged to review these updated guidances, as well as the new IEC 60601-2-33 standard, and incorporate the revised recommendations into their submission or testing plan.
FDA finalizes September 2021 guidance on Benefit-Risk Assessment for New Drug and Biological Products.
- On October 20, 2023 FDA finalized their September 2021 guidance, “Benefit-Risk Assessment for New Drug and Biological Products.” The guidance is intended to clarify how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that FDA makes about new drug applications and biologics license applications.
- Benefit-risk assessments are integrated into FDA’s regulatory review of marketing applications for new drug and biological products to demonstrate benefits of a product outweigh its risks and is thus safe. FDA’s document describes important considerations that factor into the Agency’s benefit-risk assessments, including how patient experience data can be leveraged.
- The guidance also discusses how sponsors may inform FDA’s benefit-risk assessment through development program design and conduct and present benefit and risk information in marketing applications and beyond.
- FDA issued a Request for Information (RFI) in May 2023 for input on methodological issues and other areas of interest or concern to public stakeholders, including collection and analysis of patient experience data as well as submission and evaluation of this data in the context of FDA's benefit-risk assessment or product labeling. The Agency intends to issue a Federal Register notice summarizing any input received by end of December 2023.
FDA finalizes guidance on remote monitoring devices.
- On October 19, 2023, FDA published a final guidance, entitled, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring.”
- The document supersedes the Agency’s “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” which was first published in March 2020 and was last updated in March 2023. The earlier document aimed to expand the availability and capability of remote monitoring devices to address COVID-19, expires on November 7, following the end of the public health emergency (PHE).
- With the issuance of this final guidance, the enforcement policy associated with the PHE-related guidance will continue as a formal enforcement discretion policy from the FDA. The October 2023 release continues to allow certain products to be adjusted – for example, modifications to allow use in home settings – without a new submission.
- Oximeters and clinical electronic thermometers have been removed from the guidance, which effectively eliminates enforcement discretion for these devices. Other anticipated guidance documents will address these devices.
New FDA Deputy Commissioner for Human Foods announces three priority areas for FDA’s Human Foods Program.
- Deputy Commissioner James “Jim” Jones, FDA’s first Deputy Commissioner of Human Foods, expressed his commitment to upholding and executing the new Human Foods Program framework outlined by Commissioner Robert Califf earlier this year. This new structure at FDA was announced in response to a critical report on the human foods program by the Reagan-Udall Foundation.
- Deputy Commissioner Jones announced three priority areas to work toward the Agency’s goal of protecting and promoting the health and wellness of all US consumers:
1. Preventing foodborne illness: The Agency will work closely with its federal, state, local, and international partners to further reduce the potential for food contamination. This includes continued work to fully implement the Food Safety Modernization Act, advancing the New Era of Smarter Food Safety Blueprint, as well as standing up an Office of Critical Foods to manage the regulation of infant formula and medical foods.
2. Decreasing diet-related chronic disease through improved nutrition: The Agency will work toward greater access to healthier foods and nutrition information, including a renewed emphasis on front of package labeling and reducing added sugars consumption, as well as standing up a Nutrition Center of Excellence to focus more strategically on nutrition policies and initiatives.
3. Safeguarding the food supply through the safe use of chemicals and dietary supplements: The Agency will support innovation in food ingredients and packaging, advances in safety testing and assessment methodologies, and new information sources on food composition and consumption, while maintaining as its first priority the safety of the foods available to US consumers, including our most vulnerable populations, such as children. To help meet these goals, the Agency will establish an Office of Food Chemical Safety, Dietary Supplements, and Innovation to leverage the scientific expertise in these areas.
- FDA’s 2024 budget request reflects its stated commitment to these areas by including a historic investment – an increase of $133 million – to strengthen FDA’s food safety and nutrition capacity. This request will need to be passed by Congress in the next budget cycle, which is currently on hold.
Reagan-Udall virtual public meeting on front-of-package labeling.
- The Reagan-Udall Foundation for the FDA will host a public meeting on front-of-package nutrition labeling on November 16, 2023. You must register to attend the conference.
- The meeting will include remarks by Commissioner Robert Califf and Deputy Commissioner for Human Foods Jim Jones, followed by public comment on three key topics:
1. International experience with front-of-package labeling
2. Design considerations, such as placement and color
3. Potential intersection with other nutrition-related policies, such as labeling efforts and nutrition assistance programs
- Commissioner Califf and Deputy Commissioner Jones will likely highlight the Agency’s current work on developing a front-of-packaging labeling system to quickly communicate and provide context to key nutrition information. FDA has been engaging with stakeholders on this topic and is conducting research to better understand how consumers view front-of-package labeling – and the Agency will use this research to inform its next steps.
Revised draft guidance for communications on unapproved uses.
- On October 24, 2023, FDA issued a revised draft guidance, titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers.” This is the first revision since the 2014 draft guidance was issued.
- The new draft guidance introduces the term “scientific information about unapproved uses” (SIUU) to replace the previous term, “scientific and medical publications on unapproved new uses,” from the 2014 guidance. The latest draft guidance also defines the term "SIUU communication," among others, including "firm(s)," "healthcare providers (HCPs)," "source publication," "unapproved use," and "FDA-required labeling."
- The new draft guidance outlines four major considerations for SIUU communications. First, companies are expected to consider the sources of an SIUU communication, the contents, and the presentation. Second, all publications should be from a reputable source where the content is both scientifically sound and clinically relevant. Third, firms should present this information in a “truthful and non-misleading, factual and unbiased” manner. Lastly, FDA provides recommendations for reprints, clinical reference resources, and firm-generated content.
- Interested parties should submit comments by December 24, 2023.
Final guidance for methanol testing in drug products.
- On October 17, 2023, FDA issued a final guidance, titled, “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.” This guidance replaces the guidance “Policy for Testing Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19),” published in January 2021.
- During the COVID-19 pandemic, several serious adverse health events, including death, were reported to be linked to improper use of methanol-contaminated hand sanitizers. Since ethanol or isopropyl alcohol (pharmaceutical alcohol) are widely used active ingredients in a variety of drug products, FDA is concerned that other drug products could be similarly vulnerable to methanol contamination.
- For drug products, manufacturers that use alcohol (ethyl alcohol) or isopropyl alcohol as an ingredient must follow the revised United States Pharmacopeia (USP) Isopropyl Alcohol Monograph. This monograph tests the alcohol or isopropyl alcohol ingredient using the limit test for methanol that appears in the “Identification” section of the USP Alcohol Monograph or USP Isopropyl Alcohol Monograph, respectively.
- For compounded drug products, components used in compounding must comply with the standards of the applicable USP or National Formulary (NF) monograph for the drug to qualify for the exemptions provided in sections 503A and 503B of the FD&C Act.
Final guidance on prior notice of imported food.
- On October 13, 2023, FDA issued “Prior Notice of Imported Food Questions and Answers (Edition 4),” replacing the third edition that was issued on June 16, 2016. A draft of the fourth edition was issued on September 13, 2022. This guidance document aims to help the food industry and others comply with the legal requirements established by the Prior Notice rule.
- The final guidance included two new questions (C.1.4 and E.1.7) and two updated responses (D.3.2 and E.1.6). Question C.1.4 clarifies that food imported from a country with which FDA has a Systems Recognition Arrangement or equivalence determination is not exempt from prior notice. Question D.3.2 clarifies that prior notice must be submitted to FDA, although certain authorized users can use the US Customs and Border Protection (CBP) platform for submission purposes.
- Questions E.1.6 and E.17 focus on the consequences of non-compliance. If a food will be held or refused when the food arrives at the border, FDA will communicate its decision to CBP. Notification of prior notice refusals and holds will be provided to the relevant party who submitted the prior notice (ie, submitter or transmitter) upon arrival of the article.
- A request asking FDA to review its decision of a prior notice refusal must be submitted within five calendar days of the refusal or hold.
FDA provides update on MoCRA implementation.
- In August 2023, FDA issued draft guidance that, when finalized, will provide recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA. The Agency intends to finalize the guidance as quickly as possible.
- The document aims to support the smooth implementation of the facility registrations and product listing requirements listed in the Modernization of Cosmetic Regulation Act of 2022 (MoCRA).
- In September 2023, FDA announced an opportunity to comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067), prior to the Agency’s request for Office of Management and Budget (OMB) approval.
- In October 2023, FDA announced publication of the “Structured Product Labeling (SPL) Implementation Guide with Validation Procedures,” which will help develop SPL authoring tools and, in the future, allow users may transmit SPL-formatted submissions to the Agency.
- FDA is now strongly encouraging electronic submissions to help facilitate efficiency and timeliness of data submission and Agency management. On November 1, FDA announced that it will provide more information on the launch date for submissions in the coming weeks.
FDA proposes to ban food additive and continues assessments of additional chemicals.
- On November 3, 2023, FDA proposed to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. This action is part of the Agency’s regulatory authority over ingredients added to food, which includes reassessing previously evaluated food ingredients and addressing safety concerns.
- Brominated vegetable oil (BVO) is a vegetable oil that is modified with bromine. As authorized, it is used in small amounts to keep the citrus flavoring from floating to the top in some beverages.
- FDA is issuing a proposed rule now because the Agency has recent data from studies it conducted that demonstrate adverse health effects in animals at levels more closely approximating real-world human exposure. Based on these data and remaining unresolved safety questions, the FDA can no longer conclude that the use of BVO in food is safe.
FDA prepares for the coming benefits year for its Voluntary Qualified Importer Program.
- FDA announced that will re-open its portal to receive applications for its Voluntary Qualified Importer Program (VQIP) for foods from January 1, 2024 to May 31, 2024 for the 2024/2025 benefit year.
- FDA created VQIP under the Food Safety Modernization Act (FSMA). VQIP is a voluntary, fee-based program that provides expedited review and importation of human and animal foods into the US from importers who have taken additional steps to ensure the safety and security of the products. This includes meeting all eligibility criteria, ensuring that their foreign suppliers are certified through the FDA’s Accredited Third-Party Certification Program.
- VQIP participants can import certain food products into the US with quicker entry, limited examination and sampling, FDA sampling at a preferred location, and faster lab results with the assistance of the VQIP Importers Help Desk.
- FDA routinely publishes a current List of Approved VQIP Importers, allows customers to see which importers are able to participate in these benefits.
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