FDA warns about differing complication rates for acellular dermal matrix
The FDA issued a safety communication to inform patients and health care providers that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction may have a higher chance for complications or problems. ADM, a type of surgical mesh, is developed from human or animal skin, in which the cells are removed, and the support structure is left in place. The safety communication summarizes an analysis of data from a study evaluating outcomes in patients undergoing implant-based breast reconstruction after mastectomy. The analysis showed significantly higher complication rates of explantation, reoperation and infection in patients with Flexhd and Allomax brands of ADM two years following surgery, when compared with patients who received Surgimend or Alloderm brands, or no ADM. The FDA advised patients who have had breast reconstruction with ADM and have experienced problems to file a report through MedWatch. The FDA remains committed to protecting patients' health and ensuring the safety of implant-based breast reconstruction. We will continue to monitor the latest scientific literature, as well as reports of adverse events related to ADM use to help us understand the risks and keep the public apprised of any important new data,” said Binita Ashar, director, Office of Surgical and Infection Control Devices, FDA's Center for Devices and Radiological Health.
CDC and NIH initiate COVID-19 self-testing pilot program
The CDC, in collaboration with the NIH, has launched a community health initiative called “Say Yes! COVID Test” starting in Pitt County, North Carolina, and coming soon to Chattanooga/Hamilton County, Tennessee. As many as 160,000 residents across the two communities will have access to free, rapid antigen tests that they can administer themselves to use three times a week for one month. NIH will provide the tests and evaluate the effectiveness of the initiative, which aims to determine if frequent self-administered COVID-19 testing helps residents reduce community transmission of SARS-CoV-2, the virus that causes COVID-19 disease. Participants will be able to order their test kits online for home delivery or pick them up at a local distribution site. A free online tool that also is available as a phone app will be offered to provide testing instructions, information to help understand test results and text message reminders about testing. Strong community engagement efforts are underway to ensure that vulnerable and underserved populations are aware and able to benefit from the opportunity. “This testing initiative is the first of this scale to attempt to make free, rapid, self-administered tests available community-wide in order to determine their effectiveness in our nation’s comprehensive response to the COVID-19 pandemic,” said NIH Director Francis Collins. “We hope to gain foundational data that can guide how communities can use self-administered tests to mitigate viral transmission during this and future pandemics.” The test being supplied through the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative is the Quickvue test developed by San Diego-based Quidel Corp.
GHIT invests $21M
The Japan-based Global Health Innovative Technology (GHIT) Fund announced new investments of about ¥2.3 billion (US$21 million) in four partnerships to develop lifesaving drugs for malaria, tuberculosis (TB), Chagas disease and visceral leishmaniasis. The funding also will support development of a next-generation malaria vaccine that’s heading into phase I clinical trials in Gabon and a TB rapid diagnostic kit that could improve sensitivity and specificity regardless of HIV infection. As of March 31, the GHIT portfolio included 57 ongoing projects – 30 in discovery stages, 20 in preclinical development and seven in clinical trials.
MHRA updates guidance
The U.K.’s Medicines and Healthcare Products and Regulatory Agency (MHRA) this week posted updates to three guidances – types of application, good laboratory practice (GLP) for chemical safety tests and responses to GLP and good clinical practice inspection reports. The types of application guidance instructs sponsors to include the appropriate basis when they apply for a marketing authorization and defines the various bases. The guidance on safety tests on chemicals, which covers pharmaceuticals as well as other chemicals, includes links about best practices in light of COVID-19’s impact on inspections and GLP facilities. The third guidance presents a format for responses to inspection reports. While the format isn’t mandatory, the MHRA said it is preferred. Its use “should help to reduce the time taken to reach a compliance decision after the inspection,” the agency added.