The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...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 FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, ...
Indian medical device manufacturers are enhancing GMP compliance and embracing proactive strategies to meet rising USFDA ...
Comparing Tyrzepatide and Semaglutide in the slimming drug market, with potential growth driven by increasing obesity rates worldwide. Explore more here.
The science has proven that gene therapies are effective treatments, and they have given hope to patients and their families ...
Life in the Fast Lane: FDA Issues New Draft Guidance for Accelerated Approval of Drugs and Biologics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, ...
In the ever-evolving landscape of wellness products, Gentle Wave CBD Gummies stand out as a beacon of hope for those seeking ...
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The blood-brain barrier (BBB) is a major hurdle for the development of systemically delivered drugs targeting diseases of the central nervous system (CNS). Because of this barrier there is a huge ...
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 ...
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