Search Results for Senate

Showing 1 – 25  of 119

Senate Tax Plan Seeks to Reform, Rather Than Repeal, Orphan Drug Tax Credit By Zachary Brennan - Published 10 November 2017

The Senate’s tax plan, running counter to the House’s call to eliminate the orphan drug tax credit for research on drugs to treat rare diseases, seeks to modify the credit instead.

Categories: News, US, Clinical, Research and development

Tags: GOP tax plan, Senate tax reform, Hatch, orphan drug tax credit

Many Questions, Few Answers in Senate Hearing on Opaque US Drug Pricing System By Zachary Brennan - Published 17 October 2017

The Senate Health, Education, Labor & Pensions (HELP) committee on Tuesday discussed with representatives of the pharmaceutical supply chain how the drug delivery system affects what patients pay.

Categories: News, US, Drugs, Reimbursement

Tags: pharmaceutical pricing, Senate HELP committee, PhRMA

Senate Passes 'Right-to-Try' Bill By Zachary Brennan - Published 03 August 2017

The Senate on Thursday passed via unanimous consent (meaning there was not actually a vote) a bill that claims to improve terminal patients' access to experimental drugs but, if passed in the House and signed into law, may further burden and undermine the US Food and Drug Administration (FDA).

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

Tags: Right-to-Try, right to try legislation, Senate right to try

Senate Committee Takes First Step on Rising Pharmaceutical Prices By Zachary Brennan - Published 13 June 2017

The US Senate Health, Education, Labor and Pensions Committee held the first of three hearings on rising pharmaceutical prices Tuesday, discussing the confusing system by which prices are set and possible ways to bring them down.

Categories: News, US, FDA, FTC, Crisis management, Drugs, Government affairs, Regulatory intelligence, Research and development

Tags: Senate HELP, drug prices, Pew, Manhattan Institute, Johns Hopkins, pharmaceutical prices

Senate to Take on Pharmaceutical Prices Again: Real Reform or More of the Same? By Zachary Brennan - Published 12 June 2017

The Senate Health, Education, Labor & Pensions (HELP) committee is holding a hearing Tuesday on prescription drug costs and will look to address how the drug delivery system affects what patients pay.

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

Tags: Senate HELP, Mylan, Valeant, Turing, drug prices

Senate Committee Advances FDA User Fee Reauthorization Bill By Zachary Brennan - Published 11 May 2017

The Senate Committee on Health, Education, Labor & Pensions on Thursday advanced by a vote of 21-2 a bill that would reauthorize the pharmaceutical, medical device, generic drug and biosimilar user fee agreements that expire at the end of September.

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

Tags: user fee reauthorization, Senate HELP, Hatch, Franken, Collins, FDA user fees

Senate Committee to Vote on FDA User Fee Reauthorizations By Zachary Brennan - Published 03 May 2017

Next Wednesday, the Senate Committee on Health, Education, Labor & Pensions will vote on the five-year reauthorization of the four US Food and Drug Administration (FDA) drug, medical device, biosimilar and generic drug user fee agreements.

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

Tags: user fee reauthorization, Senate HELP committee, FDA user fees

Senate Committee Advances Gottlieb Nomination as FDA Commissioner By Zachary Brennan - Published 27 April 2017

The Senate Health, Education, Labor & Pensions (HELP) committee on Thursday advanced Dr. Scott Gottlieb’s nomination to lead the US Food and Drug Administration (FDA).

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

Tags: Gottlieb, Senate FDA, FDA commissioner

Senate HELP Committee Delays Vote on Gottlieb Nomination By Michael Mezher - Published 26 April 2017

Senate HELP Committee Chairman Lamar Alexander (R-TN) on Wednesday delayed an expected vote on Scott Gottlieb's nomination to head the US Food and Drug Administration (FDA).

Categories: News, US, FDA

Tags: Scott Gottlieb, Nomination, FDA Commissioner, Senate HELP Committee

FDA Commissioner Nominee Faces Limited Opposition From Senate Committee By Zachary Brennan - Published 05 April 2017

The Senate Health, Labor, Education & Pensions Committee on Wednesday offered praise and only a few muted attacks against Scott Gottlieb, President Donald Trump's nominee to be the next commissioner of the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Business and Leadership, Government affairs

Tags: Scott Gottlieb, FDA commissioner, Senate HELP hearing

CDER, CDRH and CBER Directors Stress Importance of User Fee Reauthorizations Before Senate Committee By Zachary Brennan - Published 21 March 2017

The US Senate Health, Education, Labor & Pensions Committee on Tuesday pressed three top US Food and Drug Administration (FDA) officials for details on how plans to reauthorize their user fee programs would help to further streamline medical product approvals.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: FDA user fees, GDUFA, BsUFA, MDUFA, PDUFA, Senate HELP

Senators, Experts Weigh Bipartisan Bill to Stop REMS Abuses By Zachary Brennan - Published 21 June 2016

The Senate Judiciary Committee on Tuesday held a meeting with a panel of experts to discuss a recently introduced bill that seeks to stop branded drug companies from misusing Risk Evaluation and Mitigation Strategies (REMS) to withhold access to drug samples for bioequivalence testing necessary for bringing generic drugs to market.

Categories: News, US, FDA, Drugs

Tags: CREATES Act, REMS, Senate Judiciary

Senate Committee Advances Five More Bills as Part of Medical Innovation Package By Zachary Brennan - Published 06 April 2016

The Senate Health, Education, Labor & Pensions Committee on Wednesday advanced five more bills to the Senate floor for discussion as part of a series of 19 companion bills to the mammoth House-passed 21st Century Cures bill.

Categories: News, US, FDA, Biologics and biotechnology, Business Skills, Combination products, Drugs, Due Diligence, Ethics, Government affairs, Labeling, Medical Devices, Packaging, Postmarket surveillance, Product withdrawl and retirement, Reimbursement

Tags: Senate companion bills to Cures, 21st Century Cures, Senate Medical Innovation, Senate HELP

Senators Slam Execs of Shkreli's Former Company Over Arbitrary Price Hike on Lifesaving Drug By Zachary Brennan - Published 17 March 2016

The Senate’s Special Committee on Aging held its second hearing on pharmaceutical pricing on Thursday, this time taking shots at executives of Martin Shkreli’s former company Turing Pharmaceuticals, which only exists because of a monopoly and 5,000% price hike on a toxoplasmosis drug first approved more than 50 years ago.

Categories: News, US, Crisis management, Drugs, Reimbursement, Research and development

Tags: Martin Shkreli, Turing, Retrophin, Kalobios, Senate Aging Committee

Senate Committee Investigates FDA's Compassionate Use Program By Zachary Brennan - Published 22 February 2016

The Senate Committee on Homeland Security and Governmental Affairs late last week sent a letter to US Food and Drug Administration (FDA) Acting Commissioner Stephen Ostroff with new questions on compassionate use, FDA’s approval timelines and helping patients with terminal illnesses.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Compliance, Drugs, Due Diligence, Government affairs, Submission and registration

Tags: Senate committee and FDA, FDA approval process, compassionate use

FDA Calls for New Opioid Hearings as Califf Readies for Monday’s Senate Vote By Zachary Brennan - Published 19 February 2016

Three new expert committee meetings on opioids were announced by the US Food and Drug Administration (FDA) this week as two Democratic senators continue to oppose Robert Califf’s nomination as the next FDA commissioner ahead of a Senate vote on Monday.

Categories: News, US, FDA, Compliance, Crisis management, Postmarket surveillance, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: opioids and FDA, Califf, Senate vote for Califf, Manchin, Markey, Bernie Sanders

Senate Committee Advances Seven Bills Linked to Drug, Device Regulations and Research By Zachary Brennan - Published 09 February 2016

The Senate Health, Education Labor & Pensions Committee (HELP) on Tuesday advanced seven bills that could serve as piecemeal counterparts to House-passed Cures legislation from last year.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Quality

Tags: Senate HELP committee, drug legislation, device legislation, NIH legislation, FDA bills

FDA’s Woodcock: Generic Drug Application Backlog Will be Eliminated Before GDUFA II By Zachary Brennan - Published 28 January 2016

Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), told Senators Thursday that FDA is making significant progress in reducing the backlog of abbreviated new drug applications (ANDAs) for generics and the agency expects that it will be fully caught up by the next re-authorization of the Generic Drug User Fee Act (GDUFA) in 2017.

Categories: News, US, CDER, Active pharmaceutical ingredients, Generic drugs, Due Diligence, Government affairs, Manufacturing, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: GDUFA, generic drugs, Janet Woodcock, Senate HELP, ANDA approvals

Senate HELP Committee Votes in Favor of Califf for FDA Commissioner By Zachary Brennan - Published 12 January 2016

The US Senate Committee on Health, Education Labor & Pensions (HELP) on Tuesday voted in favor of letting the full Senate vote to approve Robert Califf as the next Food and Drug Administration (FDA) commissioner.

Categories: News, US, FDA, Government affairs

Tags: Califf, FDA commissioner, Senate HELP

Senate Committee Considers Priority Reviews to Stem the Tide of Off-Patent Drug Price Hikes By Zachary Brennan - Published 09 December 2015

Sens. Susan Collins (R-Maine) and Claire McCaskill (D-Mo.) hosted a hearing Wednesday to discuss steep price increases for off-patent drugs and what can be done to ensure patients and hospitals can afford these drugs moving forward.

Categories: News, US, FDA, FTC, Crisis management, Drugs, Ethics, Government affairs, Manufacturing, Reimbursement

Tags: drug pricing, Martin Shkreli, Turing, Daraprim, off patent drug prices, Senate committee

Health Advocacy Groups Call for Changes to Priority Review Voucher Program By Michael Mezher - Published 19 November 2015

A group of health advocacy organizations are calling on the Senate Committee on Health, Education, Labor and Pensions (HELP) to tighten requirements for obtaining priority review vouchers for drugs for tropical diseases.

Categories: News, Africa, Asia, Latin America and Caribbean, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory strategy, Research and development

Tags: Neglected Tropical Disease, NTD, Priority Review Voucher, PRV, Senate HELP Committee, MSF, DNDi

Senators Hint at Confirmation of Califf as Next FDA Commissioner By Zachary Brennan - Published 17 November 2015

Senators on both sides of the aisle offered their support for Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA) at the confirmation hearing Tuesday despite a couple of heated questions on drug pricing and industry’s influence on him.

Categories: News, US, FDA, Biologics and biotechnology, Blood, Clinical, Combination products, Drugs, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Preclinical, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Califf, Senate HELP, FDA commissioner, Senate confirmation hearing, Duke University, Margaret Hamburg, Elizabeth Warren, Bernie Sanders

Senators Investigate Rising Drug Prices as HHS Plans Action By Zachary Brennan - Published 04 November 2015

The fire stoked by rising drug prices is starting to spread through government, particularly as Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) on Wednesday announced a bipartisan Senate investigation into pharmaceutical price gouging with letters to four companies.

Categories: News, US, DOJ, FDA, FTC, Business Skills, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Elijah Cummings, Valeant Pharmaceuticals, drug prices, Senate investigation

Bipartisan Clinical Trials Compensation Bill Heads to Obama for Signature By Zachary Brennan - Published 29 September 2015

Late Monday evening, the House of Representatives cleared the final congressional hurdle for a bill that would compensate individuals who participate in clinical trials for rare diseases.

Categories: News, US, Clinical, Government affairs, Reimbursement

Tags: clinical trials, House, Senate, clinical trials legislation

Senators Question FDA's Authority to Issue 'Placeholder' Name for First Biosimilar By Alexander Gaffney, RAC - Published 01 May 2015

When the US Food and Drug Administration (FDA) approved the US' first biosimilar product, Zarxio, in March 2015, it gave the drug a unique and temporary nonproprietary name. Now a group of US senators is questioning whether FDA had the legal authority to do so.

Categories: News, US, CDER, Biologics and biotechnology, Labeling

Tags: Biosimilar, Biosimilar Naming, Nonproprietary Name, INN, Senate, HELP Committee