The FDA’s May 2021 draft guidance for post-approval studies for PMA devices did not present any regulatory novelties, but did propose tighter timelines for filing, reviewing and fulfilling post-approval study (PAS) protocols. However, a review of the agency’s PAS database suggests that both the agency and industry might have a difficult time complying with the proposed new standards for turnaround times for these studies.

After a long and tortuous development Astrazeneca plc’s anifrolumab has been approved by the FDA for the autoimmune disease systemic lupus erythematosus (SLE), setting up a rivalry with its U.K.-based counterpart Glaxosmithkline plc. The first-in-class type 1 interferon receptor antibody, the first new drug for the disease in a decade, will be marketed under the brand name Saphnelo for adults with moderate to severe disease who are receiving standard therapy.

South Korea’s Ministry of Food and Drug Safety (MFDS) has given innovative medical device designation for Te Bios Co. Ltd.’s artificial cornea, C-Clear, bringing it one step closer to becoming the first artificial cornea to be approved in the country.

Antengene Corp. Ltd. has gained the first greenlight in Asia for the oral exportin 1 (XPO1) inhibitor selinexor, in-licensed from Karyopharm Therapeutics Inc., after South Korea’s Ministry of Food and Drug Safety gave the thumbs up for its NDA. The drug has been approved in Korea to treat relapsed or refractory multiple myeloma (MM) and relapsed and refractory diffuse large B-cell lymphoma (DLBCL) in combination with dexamethasone.

The FDA has posted a final rule for its intended use policy for devices, drugs and biologics, which formalizes the elimination of the totality-of-the-evidence approach to determining the manufacturer’s intended use. While the final rule says that mere knowledge of off-label use cannot be the sole determinant of the manufacturer’s intended use, the rule still allows the FDA to infer intended use by “any relevant source of evidence,” a term that may be sufficiently squishy to be functionally equivalent to the controversial totality-of-the-evidence standard.

Post-traumatic stress disorder (PTSD) affects about 8 million Americans a year, disrupting lives with nightmares, memory loss, feelings of isolation and other negative effects. Treatment typically involves psychotherapy, but many patients do not find relief. To that end, the FDA has granted breakthrough device designation to Evren Technologies Inc. for its noninvasive Phoenix earbud device for treating PTSD.