Regulatory

Jul 06, 2017
The FDA ruling that exempts biosimilar makers from waiting an extra six months after approval to distribute a new product should help overcome delays in future biosimilar sales, writes Jill Wechsler.
Jun 19, 2017
Pharmaceutical Executive
Last month’s EFPIA and EU Health Council annual conferences highlighted the growing divisions—and resentments—between industry and governments on drug pricing. Reflector reports.
Jun 16, 2017
Congressional measures lack the support to move forward, writes Jill Wechsler.
Jun 09, 2017
Pharmaceutical Executive
A look at evidence and value in a time of social and policy change.
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
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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.
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