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  5. FDA Roundup: June 3, 2022
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FDA News Release

FDA Roundup: June 3, 2022

For Immediate Release:

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

  • Thursday, the FDA updated our March 2022 safety communication to inform consumers and health care providers about a new handpiece that has been FDA cleared for use with the Renuvion/J-Plasma device system by Apyx Medical. The Renuvion Dermal Handpiece can be used for the treatment of moderate to severe wrinkles and rhytides in patients with Fitzpatrick Skin Types I, II, or III. The Renuvion/J-Plasma device system has not been cleared to be used for any other aesthetic skin procedures.
  • Wednesday, the FDA announced an open period for applications to support the development of evidence-based, clinical practice guidelines for the management of postoperative pain in obstetric patients who have undergone surgeries, including but not limited to cesarean delivery, vaginal delivery and appendectomy during pregnancy. Safe prescribing of opioid analgesics for obstetric patients with postoperative pain is an important area where guidelines don’t currently exist; but are needed to ensure adequate pain management while balancing the special considerations on the amount and timing of opioid dosing is needed to ensure the safety of the patient and fetus. For more information visit: Grants NIH.
  • Wednesday, the FDA authorized changes to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) for the PBS/Sucrose formulation of Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older (supplied in multiple dose vials with purple caps), to include additional updated expiration dates in the Fact Sheet.  A copy of the granting letter and updated Fact Sheet are posted on the FDA’s website.
  • Tuesday, the FDA announced an open period for applications to support the development of evidence-based, clinical practice guidelines for the safe tapering of benzodiazepines. Information and guidelines on the long-term use and safe tapering of benzodiazepines are an area of important need. Addressing the safe use of benzodiazepines is a priority as the FDA continues working to confront the staggering toll of the evolving drug overdose crisis. This effort supports the Department of Health and Human Services (HHS) Overdose Prevention Strategy’s focus on primary prevention, as it is a key opportunity to reduce clinically inappropriate prescribing of medications with misuse potential. More information can be found through the following link: Grants NIH.
  • Tuesday, the FDA published the FDA Voices: “FDA’s Center for Devices and Radiological Health’s Continued Efforts to Return to Normal: Reopening for All Pre-Submissions,” by Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and William Maisel, M.D., MPH, Director, Office of Product Evaluation and Quality (OPEQ), CDRH. The article provides an update on the steps that are being taken to return the premarket program to normal operations.
  • Tuesday, the FDA announced it has opened a new period for applications for grants to develop or to support the development of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens) or to treat minor species (MUMS drugs). The maximum individual award amount is $250,000 per year per awardee, with possible, additional years of funding in certain circumstances.  Among other criteria, organization or applicants seeking funding for the development of the new any drug under investigation must hold a minor use or minor species designation granted by FDA’s Center for Veterinary Medicine. Only animal drug sponsors or their research partners are eligible to apply. 
  • In May, the FDA, the Centers for Disease Control and Prevention (CDC) and several stakeholders signed a Memorandum of Understanding (MOU) to collaborate on enhancing laboratory testing surge capacity outside of CDC and public health laboratories before and during public health emergencies. Partnerships and engagement between the public and private sector are crucial to supporting a significant increase in demand for diagnostic testing during a public health emergency and to respond to emerging public health threats before reaching the level of a pandemic. 
  • COVID-19 testing updates:
    • As of today, 437 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 302 molecular tests and sample collection devices, 85 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
    • The FDA has authorized 27 antigen tests and 7 molecular tests for serial screening programs. The FDA has also authorized 994 revisions to EUA authorizations.

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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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