USFDA

As part of the Administration’s ongoing efforts to strengthen cybersecurity in health care, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.

The FDA continues to advance new policies, modernize programs and advance opportunities for developing more targeted therapies. Using new technology platforms such as cell and gene therapies and small molecule drugs that target the genomic basis of disease, there are more opportunities to intervene in the underlying mechanisms that cause a disease, and potentially arrest and even reverse its progress.

The U.S. Food and Drug Administration approved ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient non-ABO red blood cell (RBC) types. ID CORE XT is the second molecular assay approved for use in transfusion medicine, and the first to report genotypes as final results.

The FDA is amending its food additive regulations in response to two food additive petitions, to no longer allow for the use of a total of 7 synthetic flavoring substances and flavor enhancers (adjuvants).

As part of the U.S. Food and Drug Administration’s efforts to promote drug competition and patient access, there are  advanced many policies aimed at making it more efficient to bring generic competition to the market. These are drugs that, by nature of their formulation or delivery systems for example, are harder to “genericize” under our traditional approaches. As a result, these drugs often face less competition.

US Food and Drug Administration (FDA) has approved Hemlibra® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with haemophilia A without factor VIII inhibitors.

The threat of cyber attacks is no longer theoretical. Cyber criminals and adversaries can inflict significant harm on networks through relatively simple methods, like emails or bugs known as malware.  Even when medical devices are not being deliberately targeted, if these products are connected to a hospital network, such as radiologic imaging equipment, they may be impacted.

The U.S. Food and Drug Administration approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

U.S. Food and Drug Administration permitted marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person’s bone marrow.

The U.S. Food and Drug Administration approved a new drug, Arikayce (amikacin liposome inhalation suspension), for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC) in a limited population of patients with the disease who do not respond to conventional treatment (refractory disease).