Search Results for Trump

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Trump FY 2018 Budget Blueprint: Hike in FDA User Fees? By Zachary Brennan - Published 16 March 2017

President Donald Trump’s administration released its budget blueprint for FY 2018 on Thursday, calling for a hike in user fees from industry to make up for cuts elsewhere at the US Food and Drug Administration (FDA).

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

Tags: Trump budget, FDA budget 2018, user fees, user fee reauthorization

Trump Taps Scott Gottlieb to Head FDA By Zachary Brennan - Published 10 March 2017

Dr. Scott Gottlieb, a resident fellow at the American Enterprise Institute (AEI) and former US Food and Drug Administration (FDA) official, has been selected by President Donald Trump to lead FDA as commissioner. The White House confirmed the appointment on Friday and Gottlieb will face a Senate hearing and vote.

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

Tags: Scott Gottlieb, Trump FDA, FDA commissioner

Trump Working on ‘New System’ to Increase Drug Competition By Zachary Brennan - Published 07 March 2017

President Donald Trump tweeted Tuesday morning that he’s “working on a new system where there will be competition in the Drug Industry,” though how such a system would work alongside the generic drug and biosimilar competitors, remains to be understood.

Categories: News, US, FDA, Drugs, Government affairs

Tags: Trump, drug prices, Cummings, Sanders, FDA regulations

Trump Criticizes ‘Slow and Burdensome’ FDA Approval Process By Zachary Brennan - Published 01 March 2017

In a joint session of Congress on Tuesday evening, President Donald Trump repeated his attacks on the US Food and Drug Administration’s (FDA) "slow and burdensome approval process," promising to "slash the restraints, not just at FDA but across our government."

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

Tags: Donald Trump, FDA regulations, Trump on FDA

Trump Targets Regulations Again With New Executive Order By Zachary Brennan - Published 27 February 2017

President Donald Trump on Friday took another swipe at federal regulations, signing an executive order that requires all federal agencies to create task forces to help “alleviate unnecessary regulatory burdens placed on the American people.”

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

Tags: regulations, Trump, FDA regulations, regulatory task force

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 Signals Support for 'Right-to-Try' Movement By Michael Mezher - Published 02 February 2017

In a meeting with pharmaceutical industry executives on Tuesday, President Donald Trump expressed his concern that the US Food and Drug Administration (FDA) is standing in the way of terminally ill patients accessing unapproved drugs as treatments of last resort.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Ethics, Government affairs

Tags: Trump, Right-to-Try

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

‘Two Out, One In’: Trump Signs Executive Order to Repeal Regulations By Zachary Brennan - Published 30 January 2017

President Donald Trump on Monday morning signed an executive order (EO) that would require all government agencies to eliminate two regulations for every new regulation instituted.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: OMB, hiring freeze, executive order on regulations, Trump, Trump regulations, EO on regs

FDA Staff Shortages May Get Worse With Trump’s Federal Hiring Freeze By Zachary Brennan - Published 25 January 2017

On Monday, President Donald Trump signed an executive order to freeze all federal government hiring and with the US Food and Drug Administration (FDA) lacking almost 1,000 employees, the freeze could further slow new drug, medical device and generic drug approvals.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Due Diligence, Government affairs

Tags: hiring freeze, Trump, FDA staff shortage

Potential Trump FDA Commissioner Choice: A Q&A With Dr. Joseph Gulfo By Zachary Brennan - Published 24 January 2017

A potential President Donald Trump choice for US Food and Drug Administration (FDA) commissioner spoke with Focus on Tuesday.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Due Diligence

Tags: FDA commissioner, Gulfo, Trump and FDA

Politicizing the FDA: What the Trump Win Means for New Pharma Regulations By Zachary Brennan - Published 19 January 2017

President-Elect Donald Trump on Friday will become the 45th US president and though he’s yet to name his choice for commissioner of the US Food and Drug Administration (FDA), the names of those floated to lead the agency and a recent flood of new draft and finalized FDA guidance reveal an agency bracing for change.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Trump, FDA, FDA commissioner pick, Rob Califf

Trump Sides With HHS’ Burwell and Democrats on Drug Price Negotiations By Zachary Brennan - Published 11 January 2017

President-elect Donald Trump on Wednesday opened his press conference with an unexpected shot at pharmaceutical companies and their lobbying groups on Capitol Hill, saying, "They’re getting away with murder."

Categories: News, US, Drugs, Government affairs

Tags: Donald Trump, PEOTUS, Burwell, Medicare Part D, drug price negotiations

Bipartisan House Bill Seeks to Repeal Medical Device Tax By Zachary Brennan - Published 04 January 2017

Rep. Erik Paulsen (R-MN) and a group of more than 220 bipartisan representatives on Tuesday introduced a bill that would permanently repeal the 2.3% tax on medical device companies under the Affordable Care Act (ACA).

Categories: News, US, Government affairs, Medical Devices

Tags: device tax, medical device legislation, Paulsen, Trump

Top Ten Stories From 2016 by Traffic By Zachary Brennan - Published 23 December 2016

Thanks to our readers this year for continuing to tune in on a daily basis. Here’s a rundown of the top 10 stories from 2016, a smorgasbord of randomness based on traffic. Happy holidays and happy reading!

Categories: News, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: 2016 top 10 list, Brexit, Trump, FDA guidance

2016 in Review for Drug and Device Regulations: An 11th Hour Reckoning By Zachary Brennan - Published 20 December 2016

Turn back the clock to late October and those first 10 months of 2016 look like a relatively commonplace year for the pharma and medical device industries and their US regulatory counterpart, the US Food and Drug Administration (FDA) (on the EU side, Brexit was already causing headaches for the European Medicines Agency (EMA) as early as June).

Categories: News, Europe, US, EC, EMA, FDA, MHRA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Labeling, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical regulations, year in review, Cures, Trump

Senate Democrats to Trump: Work With us to Lower Drug Prices By Zachary Brennan - Published 20 December 2016

Sens. Sherrod Brown (D-OH), Al Franken (D-MN) and 17 of their Democratic and Independent colleagues on Tuesday sent a letter to President-elect Donald Trump, urging him to combat the pharmaceutical industry’s “abusive tactics” that “price lifesaving drugs out of reach for those in need.”

Categories: News, US, Drugs, Reimbursement

Tags: Franken, Elizabeth Warren, Trump, CMS, drug prices

BIO Exec Worries User Fee Agreements Could See Setbacks Under Trump By Michael Mezher - Published 19 December 2016

The already agreed-to user fee agreements between FDA and industry could face setbacks under the incoming Trump administration.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Submission and registration

Tags: PDUFA VI, User Fees, Trump, BIO

What the Incoming Trump Administration may Mean for FDA, Biopharma and Device Companies By Zachary Brennan - Published 10 November 2016

As pharmaceutical and biotech company stocks saw a quick rise in share prices yesterday, investors seem to believe the incoming Donald Trump administration and the avoidance of a California ballot measure on drug pricing will have a positive impact on the sector as a whole, at least financially.

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

Tags: Donald Trump and HHS, Trump and FDA, drug regulations and Trump, Mike Pence