Australia’s Therapeutic Goods Administration issued guidance Thursday summarizing its annual drug and device fees and charges that will go into effect July 1, 2020. “The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities,” the guidance said. The fees laid out in the guidance cover services, such as a product evaluation, whereas a charge is a form of tax that’s applied annually based on a July 1 to a June 30 fiscal year.
The U.S. FDA has posted a new web page: Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents. The page provides answers to frequently asked questions and includes a number of adverse event reporting-related resources.
The U.S. FDA announced a virtual public meeting titled "Patient-Reported Outcomes (PROs) and Medical Device Investigations: From Conception to Implementation." The purpose of this public meeting is to discuss the benefits and challenges of incorporating the patient perspective in regulatory decision making using PRO instruments. This meeting will be held virtually Sept. 30.
The U.S. FDA has issued warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody tests. The letters were issued to: Medakit Ltd., of Sheung Wan, Hong Kong; Antibodiescheck.com, of the United Arab Emirates; and Jason Korkus and Sonrisa Family Dental dba My COVID19 Club, of Chicago. Violations outlined in the warning letters include: offering test kits for sale in the U.S. directly to consumers for at-home use without marketing approval, clearance or authorization from the FDA; misbranding products with labeling that falsely claims products are FDA approved; and labeling that bears the FDA logo, which is only for the official use by the FDA and not for use on private sector materials.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) issued guidance on urogynecology (UG) mesh implants. Information for the public and healthcare professionals was made available to support shared decision-making in the treatment of stress urinary incontinence and pelvic organ prolapse. The agency acknowledged the concerns of complications from use of synthetic implanted UG mesh devices, as well as the benefits patients have gained from these mesh procedures. The MHRA said, “UG mesh and tapes should only be used following shared decision-making between a woman and her clinician on what is the best treatment option for her, so she can make the final decision on what is best for her, and then give her informed consent to that option.” It also listed several health care bodies in the U.K. that have restricted the use of certain types of UG mesh and tapes unless there is a clinical need.