Following a year of drastic — and in some ways unprecedented — change at the U.S. Food and Drug Administration, predicting what comes next might seem difficult, but there are at least two distinct themes.
First, through its initiatives in the past year, the FDA has indicated that one of its primary objectives is to lower the cost of drugs, and second, there is an inherent tension between the priorities of the administration more broadly and that of the FDA and U.S. Department of Health and Human Services, particularly as it relates to American health.
In light of this, there are distinct legal and regulatory trends and developments that life sciences companies should track as the year unfolds, including tariffs, the Prescription Drug User Fee Act, direct-to-consumer advertising, telehealth, the voucher program, single randomized clinical trials and the agency's use of artificial intelligence.
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First, through its initiatives in the past year, the FDA has indicated that one of its primary objectives is to lower the cost of drugs, and second, there is an inherent tension between the priorities of the administration more broadly and that of the FDA and U.S. Department of Health and Human Services, particularly as it relates to American health.
In light of this, there are distinct legal and regulatory trends and developments that life sciences companies should track as the year unfolds, including tariffs, the Prescription Drug User Fee Act, direct-to-consumer advertising, telehealth, the voucher program, single randomized clinical trials and the agency's use of artificial intelligence.
Click here to read the full article.