FDA Roundup: December 19, 2023

December 19, 2023 |

6 min read

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

SILVER SPRING, Md., Dec. 19, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

Today, the FDA approved the first test that uses DNA in assessing whether certain individuals may have an elevated risk of developing opioid use disorder. As part of a clinical evaluation, the AutoGenomics Inc. AvertD test is intended to be used prior to first exposure to oral opioid pain medications in patients being considered for a 4-30 day prescription for the treatment of acute pain, such as in patients scheduled to undergo a planned surgical procedure. The AvertD test, a prescription-use only genetic laboratory test for patients 18 years and older, is to be used only with patients who consent to the test and have no prior use of oral opioid analgesics.
Today, the FDA refreshed the Know Your Treatment Options for COVID-19 Consumer Update and reminded consumers that they have several treatment options to prevent hospitalization and other serious complications of COVID-19. The FDA has approved drug treatments for COVID-19 and has authorized others for emergency use. In addition, more therapies are being tested in clinical trials to evaluate whether they are safe and effective in treating COVID-19.
Today, the FDA released four joint FDA/European Medicines Agency (EMA) question and answer (Q&A) documents on generating quality and manufacturing information for certain products included in FDA’s breakthrough therapy designation program and EMA’s PRIority MEdicines (PRIME) scheme. The documents are designed to provide clarity and insight to industry about the ongoing discussions between FDA and the EMA on this topic FDA’s breakthrough therapy designation program and EMA’s PRIME scheme are designed to help speed development of innovative products which address unmet medical needs.
On Monday, the FDA announced the launch of its Cosmetics Direct electronic submission portal for registration of cosmetic product facilities and listing of cosmetic products, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The FDA also issued a final guidance for industry on registration and listing of cosmetic product facilities and products. The final guidance also includes a new draft section, for public comment, that describes frequently asked questions and answers. The final guidance and new electronic submission portal are part of our continuing efforts to advance the implementation of MoCRA. With MoCRA’s new registration and listing requirements, the FDA will have a more complete picture of the cosmetic products distributed in the U.S.
On Monday, the Center for Tobacco Products (CTP) Director Brian King published a statement about the release of the center’s comprehensive strategic plan. The new strategic plan outlines CTP’s programmatic and workforce initiatives for the next 5 years. The center also published a policy agenda of rules and guidance documents that are in development or planned for development.
On Monday, the FDA announced beginning January 22, 2024, CDER and CBER will expand in-person face-to-face (FTF) industry meetings (with a hybrid component), to include all Prescription Drug User Fee Act, Biosimilar User Fee Act, and Over-The-Counter Monograph Drug User Fee Program (OMUFA) meeting types.
On Monday, the FDA issued a draft guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. This draft guidance is an update to the current final guidance to propose clarification about how the FDA evaluates real-world data to determine whether they are of sufficient quality for generating real-world evidence that can be used in the FDA’s regulatory decision-making for medical devices. This draft guidance also proposes expanded recommendations to sponsors considering using real-world evidence to support regulatory submissions for medical devices.
On Monday, the FDA updated the CDRH’s Customer Collaboration Portal (CDRH Portal) to help users track the progress of their De Novo classification requests. The latest portal updates are aimed at improving the user experience by providing additional information and more filters on the user’s home screen to facilitate the submission process.
What’s new in the portal:
- The option to display the device name and company name columns on the user’s home scree,
- An icon to indicate to an authorized recipient that a tracked submission has been shared with them by the official correspondent,
- The ability for a user to track their supported submission types during user fee holds and/or format holds for 510(k) originals, De Novo originals, Pre-Sub originals, and Pre-Sub supplements.

The CDRH Portal updates are a step forward in meeting the Medical Device User Fee Amendments 2022 (MDUFA V) commitments of using technology to enhance efficiency and transparency in reviewing industry submissions.

On Monday, the FDA updated the advisory for the Investigation of Elevated Lead Levels in Cinnamon Applesauce Pouches. The FDA’s onsite inspection of the Austrofoods facility in Ecuador has ended. However, the FDA investigation of the elevated lead levels in recalled cinnamon applesauce pouches continues. During the inspection, investigators collected samples of cinnamon supplied by Negasmart to Austrofoods. These samples have undergone analysis and results show extremely high levels of lead contamination, 5110 parts per million (ppm) and 2270 ppm. For context, the international standard-setting body, Codex Alimentarius Commission (Codex) is considering adopting a maximum level of 2.5 ppm for lead in bark spices, including cinnamon, in 2024. The FDA will update the advisory as information becomes available.
On Friday, the FDA granted marketing authorization to the Body Temperature Software (BTS) App intended to measure the body temperature in people of all ages, excluding premature infants. When installed on a compatible smart phone with computing platforms and infrared sensors, the BTS App can measure and provide a reading of a person’s body temperature. To use it, the person identifies the sensor on the back of the camera, removes any obstacles on the forehead, brings the sensor close to the forehead and sweeps it to the temple to begin getting a temperature reading. The BTS App is intended for over-the-counter use and it is currently compatible with one phone: the Google Pixel 8 Pro smart phone. The FDA granted marketing authorization of the BTS App to Fitbit, LLC.
On Friday, the FDA announced final approval and implementation of required labeling updates to continue efforts to address the evolving opioid crisis, and to urge health care professionals to take a more patient-centered approach when prescribing opioid analgesic products. The FDA first notified application holders of these required safety labeling updates in April 2023, at the same time the agency issued a Drug Safety Communication.
On Friday, the FDA approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial cancer (la/mUC). The FDA previously granted accelerated approval to this combination for patients with la/mUC who are ineligible for cisplatin-containing chemotherapy. View full prescribing information for Padcev and Keytruda.

Additional Resources:

FDA Newsroom

# # #

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.