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FDA Wants to Know What Regulations and Paperwork Requirements Need to Go By Zachary Brennan - Published 07 September 2017

As part of work under two executive orders, the US Food and Drug Administration's (FDA) centers on Thursday sought comments on which existing regulations and related paperwork requirements could be modified, repealed or replaced, to reduce the burden on industry while allowing FDA to continue its public health mission and fulfill statutory obligations.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: FDA regulations, paperwork reduction, one in, two out

Trump’s ‘Two Out, One In’ Regulatory Policy May Apply to Some FDA Guidance By Zachary Brennan - Published 06 February 2017

The Office of Management and Budget (OMB) late last week offered guidance to federal agencies, including the US Food and Drug Administration (FDA), trying to figure out how the new “two out, one in” executive order (EO) will impact their issuance of guidance and rulemakings moving forward.

Categories: Compliance, Crisis management, Due Diligence, Ethics, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: "two out, one in," Trump regulatory policy, FDA regulations

Health Officials' Plan B Debacle Comes Back to Haunt Regulatory Process Once Again By Alexander Gaffney, RAC - Published 05 March 2014

Categories: US, FDA

Tags: Charles Schumer, Plan B One Step, Zohydro, Kathleen Sebelius, Plan B, Latest News, DHHS

GPhA: 505(j) Provisions Saved US $1 Trillion Since 2002 By Alexander Gaffney - Published 06 August 2012

Categories: Drugs

Tags: One Trillion Dollars, Savings, 505(j), GPhA, ANDA, Latest News, Generics