Should Johnson & Johnson’s (J&J) COVID-19 vaccine be a two-dose series? While not directly asked, that question almost lurks between the lines of the FDA’s briefing document for the Oct. 15 meeting of its Vaccines and Related Biological Products Advisory Committee. The document referred to J&J’s proposed second dose as a “booster,” but the FDA isn’t asking the committee the questions it posed for the Moderna Inc. and Pfizer Inc.-Biontech SE boosters. Instead, it is inviting VRBPAC to advise on whether the second J&J dose should be administered two months or six months following the first shot.

If the FDA follows the advice of its Antimicrobial Drugs Advisory Committee, Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, will become the first drug approved in the U.S. to treat resistant or refractory cytomegalovirus infection and disease in both solid organ and hematopoietic stem cell transplant recipients. The committee voted 17-0 that the overall benefit-risk assessment favors the use of maribavir for transplant patients with refractory CMV infections both with and without genotypic resistance to the four antivirals currently used off-label to treat the infections – ganciclovir, valganciclovir, foscarnet and cidofovir.

The least burdensome principle is a critical component in industry’s understanding of the proper role of government regulation, but this principle is the subject of considerable tension between the two sides. The latest report on the FDA’s performance under the fourth device user fee agreement noted that device makers raised the least burdensome flag in less than 0.5% of 510(k) submissions filed between February 2019 and April 2021, but the report gives the agency passing grades on its handling of those potentially controversial regulatory encounters.

After nearly two years of waiting, Withings SA won FDA clearance for its Scanwatch, a smartwatch that can take an electrocardiogram and monitor for sleep disturbances indicative of sleep apnea or respiratory illnesses such as chronic obstructive pulmonary disease. The FDA action makes the watch the first cleared for both functions.

Medtronic plc’s Hugo robotic-assisted surgery system has received a CE mark for urologic and gynecologic procedures, paving the way for commercialization in Europe. The approval is a key milestone for the Dublin-headquartered company, following the launch of Hugo in Latin America and India. The company is prioritizing robotics as a major growth opportunity, but will face tough competition in the space as it goes head-to-head with established market leader Intuitive Surgical Inc. According to Medtronic, Europe could provide a significant opportunity due to its current low uptake of surgical robotic procedures.

FDA preemption of state liability law has proven controversial on a number of occasions, a fact of life resurrected by a case arising out of the Supreme Court of the State of Mississippi. The court declared that the FDA must invoke the rulemaking process for its regulation of medical product labels.