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May 15, 2019
FDA is examining and updating its programs for overseeing global operations and international affairs.
May 07, 2019
Pharmaceutical Executive
New leadership faces a host of complex initiatives to promote innovation and protect public health. Jill Wechsler reports.
Apr 24, 2019
Elvis Paćelat outlines some lessons from big pharma as medical device manufacturers succumb to new reporting obligations.
Apr 17, 2019
New FDA leader Ned Sharpless will seek further solutions to the opioid crisis and work to reduce cigarette use in adults and kids.
Apr 11, 2019
A new CDER “knowledge management” approach will see companies submit applications that can be transmitted to experts from multiple disciplines able to assess applications for new drugs and biologics in a timely and efficient manner.
Apr 07, 2019
Pharmaceutical Executive
Follow-on product naming, messaging challenge FDA, industry.
Apr 06, 2019
Pharmaceutical Executive
Europe slow to action on emerging technologies, but the complex issues clouding EHRs and gene editing, for example, offer pause.
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.
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