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Regulatory

Mar 13, 2019
Pharmaceutical Executive
Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.
Mar 11, 2019
Pharmaceutical Executive
The digitization of healthcare is paving the way to accelerate drug development in the industry, and the FDA is doing its best to support industry.
Mar 06, 2019
Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.
Feb 15, 2019
FDA came away with the largest boost in its annual budget in a decade as part of the final spending package approved by Congress last week.
Feb 07, 2019
Pharmaceutical Executive
Drug importing, advertising, rebates, and industry practices are on the table as legislators zero in on pharma pricing strategies.
Feb 04, 2019
Pharmaceutical Executive
New HHS proposed strategy to remove the current safe harbor protection from the federal Anti-Kickback Statute for rebates or discounts provided to Medicare Part D drug plans and certain state Medicaid programs.
Jan 31, 2019
FDA has restarted full operations following Congressional agreement on a continuing resolution to fund government operations for three weeks, but the situation will get worse if Congress and the White House fail to negotiate a longer-term budget for 2019.
Jan 31, 2019
Pharmaceutical Executive
The FDA proposes to use the RWE Program to guide generation of data in support of approval for new indications or to help support post-approval study requirements.
Jan 11, 2019
It’s been a banner year in the new drug approval business: CDER approved 59 novel drugs and biologics in 2018, surpassing previous high marks and improving on recent gains, with additional new products approved by the CBER boosting the total.
Jan 09, 2019
Pharmaceutical Executive
CDER priorities for 2019 include opioids, quality, safety, and innovation.
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