Alston & Bird Health Care Week in Review – March 2022 #1 | Alston & Bird

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

This week, President Biden delivered the State of the Union, in which he highlighted his administration’s response to COVID-19 and several health care initiatives. Read more about this event and other news below.

I. Regulations, Notices & Guidance

• On February 28, 2022, the Food and Drug Administration (FDA) issued guidance entitled, Medical Devices; Orthopedic Devices; Classification of the Screw Sleeve Bone Fixation Device. FDA is classifying the screw sleeve bone fixation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the screw sleeve bone fixation device’s classification.
• On March 1, 2022, FDA issued a final guidance entitled, Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders; Guidance for Industry and Food and Drug Administration Staff. This guidance document describes the processes available to mammography facilities to request additional review of an adverse appeals decision on a facility’s accreditation, and/or a suspension or revocation of certificate, and/or a patient and physician notification order.
• On March 1, 2022, FDA issued a final guidance entitled, Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics; Guidance for Industry. The purpose of this guidance is to provide advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials intended to efficiently expedite the clinical development of oncology drugs, including biological products, through multiple expansion cohort trial designs.
• On March 1, 2022, FDA issued a final guidance entitled, Inclusion of Older Adults in Cancer Clinical Trials; Guidance for Industry. This guidance provides recommendations regarding the inclusion of older adult patients in clinical trials of drugs for the treatment of cancer. For the purpose of this final guidance, older adults are those age 65 years and older. The final guidance emphasizes the particular importance of including adults over age 75 years in cancer clinical trials. Specifically, this final guidance includes recommendations for including an adequate representation of older adults in cancer clinical trials to better enable evaluation of the benefit-risk profile of cancer drugs in this population.
• On March 1, 2022, FDA issued a final guidance entitled, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Guidance for Industry. This guidance provides advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first-in-human trials, intended to…