The U.S. COVID-19 vaccine program is at risk of “booster fatigue,” which will undermine public confidence in the vaccines, several members of the CDC’s Advisory Committee on Immunization Practices (ACIP) said April 20 as they met to discuss the future of the vaccines. Rather than relying on boosters, “we need to use our expertise to advocate for something that’s better,” something that resolves the ill effects of COVID-19, whether it’s mild or severe, said Lynn Bahta, an immunization program clinical consultant for the Minnesota Department of Health.

The U.S. FDA’s device center reported April 18 that it has revoked the emergency use authorizations (EUAs) for five tests for the SARS-CoV-2 virus, a seemingly significant reduction in the inventory of tests for the COVID-19 pandemic. However, the sponsor of the test in each of these revocations requested that the EUA be revoked, an indication that the market for some types of these tests is saturated.

Perkinelmer Inc. said the Vega is a first-of-its-kind preclinical ultrasound system that will accelerate preclinical research and drug development studies of cancer, cardiovascular, liver, kidney and other diseases. The imaging platform combines hands-free automation with high-throughput capability, which the company said is a major advance over manual ultrasound scanning across the bodies of individual lab mice.

The U.S. FDA’s draft device user fee agreement was months late in arriving on Capitol Hill, a fact which also delayed the public meeting on the draft, an event that finally took place April 19. The meeting kicked off with an acknowledgement by second-time FDA commissioner Robert Califf of the growing role of user fees in FDA finances, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), said that the quality of FDA reviews was at least as important as the timeliness of those reviews even though the user fee deals include many deadline-based metrics.

Although broader use of biosimilars in the U.S. would reduce Medicare Part D spending and save beneficiaries nearly $2 million in out-of-pocket costs, plan formularies continue to discourage the use of the more affordable follow-ons, according to a recent report from the Department of Health and Human Services’ Office of Inspector General.

The FDA has granted an emergency use authorization (EUA) to Inspect IR Systems LLC, of Frisco, Texas, for the company’s namesake test that evaluates the patient’s breath for the presence of volatile organic compounds (VOC) indicative of the SARS-CoV-2 virus. The test is expected to increase the volume of testing by only 64,000 per month at the current rate of production, however, making this a technological breakthrough of limited impact on the COVID-19 pandemic.

The FDA’s June 2021 draft guidance for remanufacturing of medical devices wades into a highly complicated area of compliance for third-party servicing organizations that may not be familiar with FDA regulations, but the draft has sparked another set of concerns. Two trade associations said the draft would seem to suggest that original equipment manufacturers (OEMs) must disclose confidential trade secrets to give these third parties the information needed to service these devices, a suggestion that both the Medical Device Manufacturers Association (MDMA) and the Advanced Medical Technology Association (AdvaMed) said is clearly out of bounds.