Search Results for FDA regulations

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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

Trump Pledges to Gut FDA: Which Regulations Need to Go? By Zachary Brennan - Published 01 February 2017

With an executive order (EO) and comments from President Donald Trump yesterday calling for a massive overhaul of US Food and Drug Administration (FDA) regulations, legal experts and former FDA officials are offering some practical and creative ways the agency could clean house.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Trump executive order on regulations, FDA regulations, FDA guidance

Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated By Zachary Brennan - Published 31 January 2017

In a sign of what’s to come for the US Food and Drug Administration (FDA), President Donald Trump told pharmaceutical company CEOs Tuesday that his administration will be “cutting regulations at a level no one has ever seen before.”

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Trump, FDA regulations, pharmaceutical CEOs, Trump meeting

FDA to Issue More Guidance on 3D Printing By Zachary Brennan - Published 21 December 2016

As manufacturers use 3D printing to create devices matched to a patient’s anatomy and devices with complex internal structures, the US Food and Drug Administration (FDA) is working with universities, researchers and industry to further understand these products and issue more guidance.

Categories: News, US, FDA, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: 3D printing, FDA regulations on 3D printing, 3D printed medical devices

Cancer Gene Therapies: FDA Officials Highlight Regulatory Approaches By Zachary Brennan - Published 25 November 2015

As gene therapies begin to get a foothold among other cancer treatments, the US Food and Drug Administration (FDA) is taking a more flexible, data-driven approach for preclinical testing programs for these biologically complex products, according to a new review from five FDA officials in Cancer Gene Therapy.

Categories: News, US, FDA, Biologics and biotechnology, Blood, Business Skills, Due Diligence, Human cell and tissue, Preclinical, Quality, Regulatory strategy

Tags: cancer gene therapies, CBER, FDA regulations on gene therapy, regulatory issues for CBER

FDA Reverses Long-Standing Policy of Not Publicly Posting Individuals' Comments By Zachary Brennan - Published 17 September 2015

As part of its shift to increase transparency, the US Food and Drug Administration (FDA) said on Thursday that beginning 15 October it will publicly post individuals' comments on the regulations docket.

Categories: News, US, FDA, Compliance, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: US FDA, regulations.gov, transparency, government affairs, online comments

FDA Planning Six New Drug, Device Regulations for 2015 By Alexander Gaffney, RAC - Published 24 November 2014

The US Food and Drug Administration (FDA) has released a list of regulations it plans to release in 2015, including six new rules set to affect pharmaceutical and medical device development.

Categories: News, US, FDA, Regulatory intelligence

Tags: Unified Agenda, Planned FDA Regulations, Proposed FDA Regulations

Six New FDA Regulations to be Introduced in 2014, Including Major Change in IND Reporting By Alexander Gaffney, RAC - Published 27 May 2014

The US Food and Drug Administration (FDA) has released an updated list of regulations it is planning to seek in 2014, known as its "Unified Agenda," outlining six new rules it says it intends to propose in 2014.

Categories: News, US, FDA, Distribution, Drugs, Manufacturing, Medical Devices

Tags: US, FDA, Unified Agenda, Proposed Rule, Regulation, Final Rule, 2014 FDA Regulations, DQSA