Search Results for Senate HELP

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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 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 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

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

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

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 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

Senate Launches Bipartisan Effort to Assess, Change how FDA Regulates Medical Products By Alexander Gaffney, RAC - Published 03 February 2015

The US Senate's Health, Education, Labor and Pensions (HELP) Committee is in the early stages of launching its own legislative process intended to help reform the ways in which the US Food and Drug Administration (FDA) regulates drugs and medical devices, it has announced.

Categories: News, US, FDA, Government affairs

Tags: Senate, HELP Committee, 21st Century Cures Initiative, Innovation for Healthier Americans, Legislation, 21st Century Cures Act

US Senate Unveils Major Changes to FDA Program in Hopes of Fighting Ebola By Alexander Gaffney, RAC - Published 12 November 2014

Legislators in the US Senate have unveiled a new piece of legislation meant to incentivize companies to go after the Ebola virus by making critical and long-sought changes to a US Food and Drug Administration (FDA) regulatory program.

Categories: News, US, FDA, Drugs

Tags: Ebola, Priority Review Voucher System, FDAAA, Priority Review, Legislation, Congress, Senate, HELP Committee, Tropical Disease Priority Review Voucher