News | Coronavirus (COVID-19) | June 23, 2020

FDA Keeps on Track With Medical Product Application Goals

FDA maintains the pace of meeting its goals on applications for medical products during the pandemic

Stephen M. Hahn, M.D., Commissioner of Food and Drugs - Food and Drug Administration

Stephen M. Hahn, M.D., Commissioner of Food and Drugs - Food and Drug Administration

June 23, 2020 — On June 23, 2020, Stephen M. Hahn, M.D., Commissioner of Food and Drugs, released a statement regarding the United States Food and Drug Administration (FDA) maintaining the pace of meeting its goals on applications for medical products during the pandemic. Hahn stated:

"One of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the timely reviews of medical product applications despite a surge in volume of work and practical constraints that may impact our ability to conduct on-site inspections. The public counts on the FDA to review and, when appropriate, to approve or clear medical products that are so important to patients and health care providers.

"I am pleased to announce today that the FDA has maintained the same pace of meeting its goals on review of applications for medical products during the pandemic that it has maintained in recent years. For instance, we are currently on target to meet our user fee goals for drugs this year by reviewing and taking timely action on at least 90% of brand, generic, and biosimilar drug applications even during the pandemic. For many of the medical products we regulate, including medical devices, biologics and animal drugs, the impact of the pandemic on user fee review timelines has not been significant and, at this time, we anticipate meeting medical device, biologics, and animal drug timeline goals for our decisions on marketing applications, although it is possible that we will not be able to sustain our current level of performance indefinitely.

"So far, we are right in line with our strong past performances. I regard this as a remarkable achievement. Congressionally-authorized user fees provide resources to enhance the efficiency of the review process. We continue to take our responsibility to fulfill our user fee commitments very seriously, especially in the face of a pandemic.

"This achievement reflects the dedication and commitment of the FDA staff. We all had to adjust to a new work environment during the public health emergency. For instance, per State Department travel guidance, we have postponed routine foreign inspections. But the review of applications for medical products continued, as did mission critical inspections of domestic and foreign manufacturing facilities to ensure compliance with our high standards for quality.

"I am proud of our review teams for meeting the goals established by our various user fee commitments, and I am especially proud of our field force, including our investigators, for conducting the mission critical inspections despite the severe limitations on travel. FDA staff has been very innovative and strategic in completing facility assessments. For example, when it was impossible to conduct inspections on site, the FDA has assessed records of recent inspections to review the facility’s compliance history, used information shared by foreign regulatory partners through mutual recognition and confidentiality agreements, and conducted reviews of documents typically evaluated on site to assess the processes implemented at the manufacturing facility. 

"As we look to the future, we know that the virus remains a health threat, and we need to be sure that we are prepared to continue reviewing future applications, not just for COVID-19-related products but for all medical products that require premarket review. Our medical review staffs stand ready to continue their work to ensure that data support the safety and effectiveness of medical products.

"We are prioritizing future inspections based on the expected health benefit of the products under review and the overall importance in advancing medical care, taking into account our user fee commitments. And we will use other tools to help prioritize future inspections. Agency leadership continues to engage in discussions about how we will augment this work, and we are committed to taking a step-wise approach and weighing the unique and unprecedented circumstances of COVID-19 affecting all corners of the world.

"Of course, we recognize that potential therapies to treat patients with COVID-19 are a top priority. Our process for setting priorities will be based on the data supporting a new product, patient safety and other factors. We also want to be sure that the manufacturing capacity for therapies to treat patients with COVID-19 receives attention. We also are paying special attention to the review of generic applications for products used to treat COVID-19 patients.

"I want to thank our staff for all their incredibly hard work. It has meant that the public can continue to have complete confidence in our review of medical products and in our unwavering commitment to ensuring that medical products meet our high standards for safety and effectiveness."

For more information: www.fda.gov

Related Content

Right mediolateral oblique (MLO) mammograms for different women with the same breast thickness but varying breast density.

Right mediolateral oblique (MLO) mammograms for different women with the same breast thickness but varying breast density.

News | Breast Imaging | July 30, 2021
July 30, 2021 — Volpara Health, a global health technology software leader providing an integrated breast care platfo
According to ARRS’ American Journal of Roentgenology (AJR), the resources required to warm iohexol 350 to body temperature before injection for computed tomography (CT) may not be warranted, given the lack of observed practical benefit.

Values represent number of patients, with percentage in parentheses and 95% CI in brackets (not reported for levels of severity of allergic/allergic-like reactions). 95% CIs were calculated using the Clopper-Pearson exact formula. For events with zero frequency, one-sided 97.5% CIs are provided.

News | Contrast Media | July 30, 2021
If you plan to attend HIMSS21 Aug. 9-13 in Las Vegas, be sure to note that due to health and safety updates, masks will now be required for attendees and exhibitors.

Getty Images

News | HIMSS | July 28, 2021
July 28, 2021 —If you plan to attend HIMSS21 Aug.
Researchers from the School of Biomedical Engineering & Imaging Sciences at King's College London have automated brain MRI image labeling, needed to teach machine learning image recognition models, by deriving important labels from radiology reports and accurately assigning them to the corresponding MRI examinations

Getty Images

News | Magnetic Resonance Imaging (MRI) | July 28, 2021
July 28, 2021 — Researchers from the School of Biomedical Engineering & Imaging Sciences at...
A new Harvey L. Neiman Health Policy Institute study found that patients paid 12% of the costs of secondary imaging interpretation out-of-pocket. Such secondary interpretations are increasingly performed for complex patients, but patients’ liabilities and paid out-of-pocket costs were not previously known.

Getty Images

News | Radiology Imaging | July 28, 2021
July 28, 2021 — A new Harvey L.
Recommendations address when and how radiation therapy should be used and outline best practices for patient-centered care

Figure 1. The guideline also includes treatment algorithms for initial local management (Figure 1) and local management following an unplanned excision (Figure 2).

News | Radiation Therapy | July 27, 2021
July 27, 2021 — A ...