FDA Roundup: March 31, 2023

SILVER SPRING, Md., March 31, 2023 /PRNewswire/ --Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

• This week, the FDA approved three first-time generic animal drugs, bringing additional options to the table for veterinarians, pet owners and animal producers:
  • On Wednesday, the FDA approved Modulis for Cats, the first generic cyclosporine oral solution for cats. Modulis for Cats is indicated for the control of certain skin conditions resulting from a disease called feline allergic dermatitis.
  • On Thursday, the FDA approved Tauramox, the first generic moxidectin injectable solution indicated for beef and nonlactating dairy cattle for the treatment and control of internal and external parasites in cattle.
  • Today, the FDA approved the first generic Maropitant Citrate tablets for the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs.
• Today, the FDA published the FDA Voices: “National Minority Health Month: Better Health Through Better Understanding,” by RDML Richardae Araojo, Pharm.D., M.S., Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity. As the FDA observes National Minority Health Month this April, we are highlighting the Enhance Equity Initiative and our work to raise awareness on the importance of improving the health of racial and ethnic minority populations and reducing health disparities. This year’s theme, “Better Health Through Better Understanding,” supports our mission to promote and protect the health of diverse populations through research and communication of science that addresses health disparities.
• Today, the FDA granted marketing authorization for the Masimo SafetyNet Opioid System, a monitoring device intended to recognize and respond by a series of escalating notifications when an individual may be experiencing Opioid Induced Respiratory Depression (OIRD) due to opioid use or overdose. The device monitors several physiological markers to detect the impairment of oxygenation due to opioid use and uses software that can notify personal contacts and/or trigger a wellness call to the device user by an Emergency Medical Service dispatch when a person may be experiencing OIRD, to help ensure they receive necessary treatment intervention, such as naloxone. The Masimo SafetyNet Opioid System is intended for individuals 15 years of age and older. It can be used in a hospital or in-home setting for individuals taking prescribed opioid medications, or those using opioids illicitly.
• On Thursday, the FDA published “Catching Up with Califf: The U.S. has One of the Safest Food Supplies in the World,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. This is the inaugural “Catching Up with Califf,” a new shorter version blog from Dr. Califf that will be featured through the FDA Voices platform. The FDA has accomplished a tremendous amount in the last 10 years to make the American food supply as safe as it’s ever been. The agency has been using advanced technology to cut back on foodborne illness cases.
• On Thursday, the FDA issued a safety communication to inform patients, caregivers and health care providers about our evaluation of safety concerns with the use of certain dental devices, specifically fixed (non-removable) palatal expanders used on adults to remodel the jaw or to treat conditions. The FDA is aware of these devices being used to treat conditions such as obstructive sleep apnea and temporomandibular joint disorder of the jaw, and to remodel the jaw in adults. However, the safety and effectiveness of these devices intended for these uses have not been established, and these devices are not cleared or approved by the FDA.
• On Thursday, the FDA authorized marketing for Happiest Baby, Inc.'s SNOO Smart Sleeper, an over-the-counter infant sleep system. The SNOO Smart Sleeper bassinet plus the SNOO Sleep sack are jointly intended to facilitate a supine position (lying flat on the back) during sleep for infants up to six months of age who are not yet able to roll over consistently. According to the National Institute of Child Health and Human Development, infants who are placed in a supine sleep position are at a lower risk of Sudden Infant Death Syndrome/Sudden Unexpected Infant Death (SIDS/SUID). As part of the device’s evaluation, the FDA reviewed data comparing the incidence of reported SIDS/SUID in SNOO users to historical CDC SIDS/SUID data. Although this data comparison was not sufficient to determine whether the device could prevent SIDS/SUID, the data did demonstrate the device did not increase the risk of SIDS/SUID in the study population. Therefore, the device is not intended to prevent or reduce the risk of SIDS/SUID. At this time, there are no infant sleep systems or infant positioners authorized for marketing by the FDA to prevent or reduce the risk of SIDS/SUID. The American Academy of Pediatrics and the National Institute of Child Health and Human Development recommend that the best way to reduce the chance of SIDS/SUID is to create a safe sleep environment for a baby.
• On Thursday, the FDA released new print and multimedia content on ORA News and Stories on fda.gov. Articles include a feature story highlighting the 70^th anniversary of the agency’s public affairs specialists working in communities nationwide, building public trust and combating misinformation and disinformation; an ORA Viewpoints blog article titled Public Service Milestones and Intentions for the Future, a reflection on the benefits of the FDA public health education program and the talented experts who have served over the decades and made significant contributions to the program, the FDA and the American people. ORA News and Stories is a webpage on FDA.gov that features the news, expert perspectives and stories about ORA’s work in protecting public health.
• On Wednesday, the FDA issued a guidance for immediate implementation: Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act. Beginning on March 29, 2023, manufacturers of cyber devices are now required to include information to demonstrate reasonable assurance that their cyber device and related systems are cybersecure. The new authorities provided in the Omnibus represent a significant step forward in the FDA’s role in regulating cybersecurity as part of a medical device’s safety and effectiveness. The FDA generally intends not to issue “refuse to accept” decisions for premarket submissions for cyber devices submitted before October 1, 2023, based solely on information required by section 524B of the FD&C Act. Instead, the FDA will work collaboratively with sponsors of such premarket submissions as part of the interactive and/or deficiency review process.
• On Wednesday, the FDA authorized for marketing the Bioretec Ltd. RemeOs Screw LAG Solid, a first-of-its-kind absorbable metal alloy screw intended for the surgical internal fixation of bone fractures and after osteotomies (e.g., planned bone cuts designed to reshape or realign bones, such as for the correction of deformities or malalignments). It is indicated for fixation of the medial malleolus, a small bony prominence of the inner side of the ankle critical to joint stability. The implants serve as temporary fixation and stabilization devices until fusion (healing) of bone fragments common to both fractures and osteotomies. They are intended to be used for [skeletally mature] adults.
• On Wednesday, the FDA informed consumers that some naloxone products are safe and effective for nonprescription (over-the-counter, or OTC) use. FDA-approved naloxone products are an important tool to reverse opioid overdose in health care and community settings. That’s one of many reasons the FDA is working to help facilitate access to naloxone.
• On Wednesday, the FDA announced the launch of the Lupus Accelerating Breakthroughs Consortium (Lupus ABC), a first-of-its-kind public-private partnership with the Lupus Research Alliance focused on addressing challenges impacting lupus clinical trial success. Lupus ABC will convene people living with lupus, medical societies, industry, academic clinical researchers and scientists, the FDA and other federal agencies to address scientific hurdles that are beyond the capacity of any single entity. By connecting those with lived experience with all parties involved in lupus treatment research, the FDA hopes to advance the development of urgently needed treatments for lupus.
• COVID-19 testing updates:

• • As of today, 446 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 84 antibody and other immune response tests, 61 antigen tests and one diagnostic breath test. There are 78 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 28 EUAs for antigen over-the-counter (OTC) at-home tests and five for molecular OTC at-home tests.
  • The FDA has authorized 46 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1331 revisions to EUA authorizations.

Additional Resources:

• FDA Newsroom

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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, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration