On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for ...
The US Food and Drug Administration (FDA) has granted pre-market approval (510K) to HLB Life Science’s Sofject disposable ...
Neffy for severe allergic reactions and Dupixent for chronic obstructive pulmonary disease (COPD), which all gained FDA approval this year. These medications are "slated to make a big clinical ...
Life in the Fast Lane: FDA Issues New Draft Guidance for Accelerated Approval of Drugs and Biologics
In 1976, the Eagles released the song, “Life in the Fast Lane,” as part of their iconic album, Hotel California. Approximately 16 years later, ...
Let FDA approve NPIs While I have grave concerns about regulatory capture during the drugs approvals process at the Federal ...
As we enter the new year, all eyes are on the biotech companies awaiting key FDA decisions in January. In 2024, the FDA approved 50 ...
Specifically, devices that are approved through a process that does not require any clinical evidence for FDA authorization should not automatically meet Medicare coverage criteria, which ...
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