Regulatory

Jun 08, 2017
Pharmaceutical Executive
In the 21st Century Cures Act, Congress excluded from FDA regulation certain clinical decision support, or CDS, software.
May 23, 2017
CBER is gearing up to facilitate the development and approval of regenerative medicine advanced therapies, as defined by the 21st Century Cures Act.
May 22, 2017
Pharmaceutical Executive
Now that the Senate has confirmed Scott Gottlieb as FDA commissioner, Jill Wechsler outlines a few of the issues awaiting the agency's new leader.
May 16, 2017
There will be 13 full-time positions dedicated to creating and providing guidance in the emerging subject area.
May 08, 2017
The agency hopes to better use global resources and avoid duplicate inspections of foreign facilities.
May 04, 2017
Effectively addressing prior authorization challenges as part of a company’s core sales and marketing tactics can yield tangible and substantial benefits, writes Dan Rubin.
Apr 10, 2017
Nine months on from the 2016 EFPIA Disclosure Code deadline — requiring all member companies to publish data concerning their transfer-of-value transactions to HCPs — EFPIA's Andrew Powrie-Smith offered an update on media and industry responses.
Apr 10, 2017
If pharma companies want to hold their own in the current climate, they must embrace rather than resist market change, writes Peter Muller.
Apr 07, 2017
Curing cancer is not an impossibility anymore. Essential to any effort to achieve this will be the policies coming from President Trump’s administration, writes James Nathanielsz.
Apr 07, 2017
Pharmaceutical Executive
Pilot study affirms the value of a standards-based solution for prescription drug traceability—and the need to start now to meet compliance deadlines for the Drug Supply Chain Security Act.
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