FDA Summary: May 12, 2023


For quick release:

Today, the US Food and Drug Administration is offering an at-a-glance summary of news from around the agency.

  • Today, FDA updated the medical device shortage information on the FDA.gov website to reflect the end of the COVID-19 public health emergency (PHE), including answers to questions such as:
    • Covid-19 Public Health Emergency (PHE) Notice Expired Are 506J Notices Needed Now?
    • What is the status of FDA guidance documents related to Section 506J?
    • How do I submit voluntary 506J notices?
  • FDA continues to work with federal partners and other supply chain stakeholders to prevent and address medical device shortages. FDA will continue to monitor the supply chain and update the device shortage list and device discontinuation list as new information becomes available.
  • On Thursday, the FDA issued a Drug Safety Communication to standardize prescribing information for amphetamine and methylphenidate products, a class of stimulants used to treat attention deficit/hyperactivity disorder (ADHD) and other disorders. The amendments will clearly inform patients, carers and healthcare professionals of the risks associated with their medicines. Required updates include information on misuse and abuse (also called nonmedical use), addiction, and overdose.
  • On Thursday, the FDA published FDA Voice: “Lessons Learned from COVID-19 Are Informing Preparation for Future Public Health Emergencies,” by Robert M. Officer. The US Department of Health and Human Services plans to declare a federal public health emergency for COVID-19, which expires on May 11, 2023, under the Public Health Service Act. Covid-19 is a high priority, and FDA will continue to work with many others. Activities to protect and promote public health. And while the virus is still with us, causing illness and death in some cases, the good news is that we now have more tools to help protect many in our families and communities from the more harmful effects of COVID-19.
  • On Wednesday, the FDA published FDA Voices: “FDA Releases Two Discussion Papers to Promote Artificial Intelligence and Machine Learning in Drug Development and Manufacturing,” by Patricia Cavazzoni, MD, director of the Center for Drug Evaluation and Research. The FDA’s discussion papers, “Using Artificial Intelligence and Machine Learning in Drug and Biological Product Development” and “Artificial Intelligence in Drug Manufacturing,” are intended to engage interested parties in the medical product development community, such as pharmaceutical companies. Ethicists, academia, patients and patient groups, and global peer regulatory and other authorities on the use of AI/ML in drug and biological development and the development of medical devices for use with these therapies.
  • On Wednesday, the FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a joint letter to healthcare providers clarifying buprenorphine prescribing recommendations. In the letter, both agencies affirmed their commitment to addressing overdose crises by reducing barriers to access to evidence-based treatments and providing person-centered care for substance use disorders.
  • The FDA announced Wednesday that a joint project with the National Institute of Standards and Technology aims to develop tools developers can use to detect unintended effects of genome editing in animals. These science-based tools add to the knowledge base of all developers and inspectors.
  • On Wednesday, the FDA released a discussion paper titled “Using Artificial Intelligence and Machine Learning in Drug and Biological Product Development.” The discussion paper aims to promote mutual learning and discussion on artificial intelligence and machine learning (AI/ML) with stakeholders including industry and academia. The agency is soliciting comments on the opportunities and challenges of using AI/ML in drug development and medical device development. For more information on the discussion paper and how to comment, please see the Federal Register notice and visit the Artificial Intelligence and Machine Learning for Drug Development webpage.
  • On Tuesday, the FDA approved the marketing of Swing Therapeutics’ Stanza, a smartphone-based prescription drug that offers acceptance and commitment therapy (ACT), which is a form of cognitive behavioral therapy (CBT). This device is indicated for the treatment of fibromyalgia symptoms in adult patients. The program uses ACT and CBT approaches to develop psychological flexibility to improve fibromyalgia symptoms.
  • On Friday, May 5, the FDA approved Librela (bedinvetmab injection) for the management of osteoarthritis-related pain in dogs. Librala is the first monoclonal antibody (mAB) approved by the FDA for use in dogs. On January 13, 2022, the FDA approved a mAb for cats, the first mAb approved by the FDA for use in any animal species, a new veterinary drug, and the first treatment for the management of OA-related pain in cats.

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

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