Search Results for House

Showing 1 – 25  of 152

White House Commission on Opioids to Trump: Declare a National Emergency By Zachary Brennan - Published 31 July 2017

The White House Commission on Combating Drug Addiction and the Opioid Crisis on Monday urged President Donald Trump to declare the opioid crisis a national emergency under the either the Public Health Service Act or the Stafford Act.

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

Tags: opioids, White House opioid commission, Chris Christie, addiction

White House Doubles Down on Call to Fund FDA Entirely With Industry Fees By Zachary Brennan - Published 13 July 2017

Following the House of Represenatatives' passage of the bill to reauthorize US Food and Drug Administration (FDA) user fees on Wednesday, the White House doubled down on its earlier call to amend the agreements so that FDA is entirely funded by medical products industries.

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

Tags: White House, Donald Trump, FDA user fees, Right-to-Try, FDA bill

Trump Administration Officials Huddle at White House to Discuss Drug Pricing By Zachary Brennan - Published 16 June 2017

A White House spokesman confirmed to Focus that a meeting took place at the White House on Friday "as part of the ongoing discussions to reduce the burden of the high cost of drug prescriptions and unleash a wave of innovation to develop cures and treatments for patients."

Categories: News, US, FDA, Drugs

Tags: Trump, drug pricing, White House meeting on drug prices

European Regulatory Roundup: EMA Offers Guidance on Assessing Periodic Safety Update Reports (13 April 2017) By Nick Paul Taylor - Published 13 April 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: EpiPens, House of Lords, drug pricing, EMA guidance

Cybersecurity: House Committee Looks to Build on Public-Private Partnerships By Michael Mezher - Published 04 April 2017

The House Energy & Commerce Committee on Tuesday held a hearing looking into ways to improve cybersecurity across the healthcare sector.

Categories: News, US, FDA, Medical Devices

Tags: Cybersecurity, Information Sharing and Analysis Centers, ISACs, NH-ISAC, House Energy & Commerce

FDA Office of Regulatory Affairs Realignment to Begin in May By Michael Mezher - Published 28 March 2017

The US Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA), which carries out the agency's inspection program, will officially begin a major overhaul in the coming weeks, according to FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren.

Categories: News, US, FDA, Compliance, Medical Devices

Tags: Office of Regulatory Affairs, Inspections, Jeffrey Shuren, House Energy & Commerce

House Committee Asks FDA for More Info on Contaminated Heparin Investigations By Zachary Brennan - Published 15 March 2017

Four Republicans on the House Committee on Energy & Commerce sent a letter on Wednesday to US Food and Drug Administration (FDA) acting commissioner Stephen Ostroff seeking additional information on FDA’s investigations into a heparin contamination crisis from a decade ago that are now closed.

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

Tags: heparin, China heparin, House E&C, FDA investigations

UK on Brexit Implications: ‘Significant Benefits’ to Remain Part of EMA By Zachary Brennan - Published 14 March 2017

The UK government’s EU External Affairs Subcommittee on Tuesday published a report on the implications of Brexit on trade, noting that there may be “significant benefits” in continuing UK participation in the European Medicines Agency (EMA).

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Drugs

Tags: Brexit, UK in EMA, House of Lords

New House E&C Chairman to Consider Value-Based Drug Price Negotiations By Zachary Brennan - Published 02 February 2017

The newly minted chairman of the influential House Energy & Commerce Committee is looking to tackle pharmaceutical price gouging with a new bill and comments on how there need to be more negotiations to bring down prices.

Categories: News, US, Drugs, Reimbursement

Tags: Walden, House E&C, Schrader, Merck, CMS drug negotiations

Updated: Congress Looks to Force FDA Into Rewriting Major Generic Drug Labeling Rule By Zachary Brennan - Published 13 April 2016

As Congress looks to pass a spending bill for FY 2017 by Friday, the House Appropriations Committee has released a new bill with a modest amount of new funding for the US Food and Drug Administration (FDA) and new demands on how FDA should write a controversial and major final rule on generic drug labels.

Categories: News, US, FDA, Generic drugs, Labeling, Postmarket surveillance

Tags: generic drug labeling, Congressional spending, House appropriations

FDA Defends Plans to Regulate LDTs at House Hearing By Michael Mezher - Published 17 November 2015

The US Food and Drug Administration (FDA) is making it clear to Congress that it's up to the task of regulating lab developed tests (LDTs).

Categories: News, US, CDRH, Government affairs, In vitro diagnostics, Medical Devices, Submission and registration

Tags: Laboratory developed tests, LDTs, House Energy and Commerce Committee, E&C

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

FDA Legislation Tracker By Alexander Gaffney, RAC - Published 03 June 2015

Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory intelligence

Tags: FDA Legislation Tracker, Legislation, Bill, House, Congress, President, FDA Legislation, FDA Bill

Regulatory Explainer: The (Updated) 21st Century Cures Act By Alexander Gaffney, RAC - Published 30 April 2015

The US House Energy and Commerce (E&C) Committee has released an updated draft of a piece of legislation which proposes dramatically overhauling the way in which the US Food and Drug Administration (FDA) regulates many healthcare products.

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

Tags: Regulatory Explainer, 21st Century Cures Act, 21st Century Cures Initiative, Cures Act, House, Legislation, Congress

Legislation Overhauling Approval of Drugs, Devices Coming Next Week By Alexander Gaffney, RAC - Published 22 April 2015

Congressional legislators are preparing to unveil the next iteration of the 21st Century Cures Act, a massive piece of draft legislation intended to overhaul the way in which the US Food and Drug Administration (FDA) regulates and incentivizes the development of new medical products.

Categories: News, US, FDA

Tags: 21st Century Cures Act, 21st Century Cures Initiative, House, Legislation, Bill, Congress

Bill Would Give Some Reformulated Drugs Extra Protection from Generics By Alexander Gaffney, RAC - Published 18 March 2015

New legislation introduced in the US House of Representatives would give some pharmaceutical products an extra two years of marketing exclusivity if their sponsors are able to demonstrate that the redesigned or reformulated drugs improve adherence, decrease abuse or otherwise make the drug safer to take.

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

Tags: Bill, Legislation, Congress, House, PATIENT Act, Promoting Access for Treatments Ideal in Enhancing New Therapies Act

House Passes DEA Reform Bill Changing Definition of When a Drug is 'Approved' By Alexander Gaffney, RAC - Published 17 March 2015

The US House of Representatives has passed a new bill which promises to accelerate market access for new pharmaceutical products requiring review by the US Drug Enforcement Administration (DEA), and also changes the definition of what drug "approval" means for some new drug products.

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

Tags: DEA, Legislation, House, Congress, Improving Regulatory Transparency for New Medical Therapies Act, Drug Approval, CSA, Controlled Substances Act, Scheduling, Drug Enforcement Administration

DEA Scheduling Reform Bill Moves Forward in House By Alexander Gaffney, RAC - Published 13 February 2015

The House of Representatives’ Energy and Commerce Committee has voted in favor of new legislation that would reform the way in which the US Drug Enforcement Administration (DEA) schedules new drug substances in the hopes of allowing patients to access new therapies more quickly.

Categories: News, US, CDER, Drugs

Tags: DEA, Drug Enforcement Administration, Improving Regulatory Transparency for New Medical Therapies Act, House, Legislation, Bill

Obama: Let's Take Food Regulation out of FDA By Alexander Gaffney, RAC - Published 02 February 2015

The US Food and Drug Administration (FDA) could stand to lose all of its authority to regulate food products, potentially including dietary supplements, under a new proposal unveiled by President Barack Obama this week.

Categories: News, FDA, Nutritional and dietary supplements

Tags: Barack Obama, White House, FDA Budget, Food Safety Administration, FSA

10 Proposals Worth Paying Attention to in the 21st Century Cures Act By Alexander Gaffney, RAC - Published 30 January 2015

Earlier this week, the House Energy and Commerce Committee released a draft of an ambitious new bill, the 21st Century Cures Act. The legislation, if enacted, would radically alter the way in which drugs and devices are regulated in the US. Within the 393-page legislation are dozens and dozens of proposals, large and small. But which ones are especially worth paying attention to? We're glad you asked. What follows is our analysis of which proposals are likely to attract the most attention—and controversy—in the coming months.

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

Tags: 21st Century Cures Act, 21st Century Cures Initiative, House, Congress, Legislation

BREAKING: Congress Seeks Dozens of Major Regulatory Reforms in New Bill By Alexander Gaffney, RAC - Published 27 January 2015

The US House of Representatives' Energy and Commerce (E&C) Committee today released a long-anticipated discussion draft of its 21st Century Cures Act, an ambitious attempt to overhaul the way the US Food and Drug Administration (FDA) regulates new healthcare products in the hopes of incentivizing the creation of new products to treat patients.

Categories: News, US, CBER, CDER, CDRH, Advertising and Promotion, Biologics and biotechnology, Clinical, Drugs, In vitro diagnostics, Medical Devices, Orphan products, Submission and registration

Tags: 21st Century Cures Act, Congress, FDA Legislation, House, Energy and Commerce Committee

When is a Drug a 'New' Drug? Legislation Seeks to Change Definition By Alexander Gaffney, RAC - Published 26 January 2015

New legislation introduced in the US House of Representatives last week seeks to incentivize the development of new combination drugs by redefining what a "new" drug really is.

Categories: News, US, CDER, Combination products, Drugs, Submission and registration

Tags: FDC, Fixed-Dose Combination, New Drug, Legislation, House, Congress

DEA Scheduling Process Targeted by Legislators Hoping to Speed up Drug Approvals By Alexander Gaffney, RAC - Published 21 January 2015

The House of Representatives is in the advanced stages of considering legislation that could make it easier for some drug products to reach the market after being approved by the US Food and Drug Administration (FDA).

Categories: News, US, Drugs, Submission and registration

Tags: DEA, Drug Enforcement Administration, CSA, Controlled Substances Act, Legislation, House, Improving Regulatory Transparency for New Medical Therapies Act, Bill

New Bill Would Reduce FDA Burden on Research-Use Devices By Alexander Gaffney, RAC - Published 14 January 2015

A new bill introduced in the House of Representatives by a prominent Republican legislator would make it easier for companies to distribute investigational medical devices explicitly labeled as being "for research use only (RUO)."

Categories: News, US, CDRH, In vitro diagnostics

Tags: RUO, IO, Guidance, Legislation, Michael Burgess, House, Congress, Bill, Medical Testing Availability Act of 2015, Research Use Only

Legislation Seeks to Overhaul FDA's Compassionate Use Program By Alexander Gaffney, RAC - Published 09 December 2014

New legislation introduced in the House of Representatives would makes changes to the US Food and Drug Administration's (FDA) "expanded access"—sometimes called "compassionate use"—policies in the hopes of making it easier for terminally ill patients to access potentially life-saving drugs.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Drugs

Tags: Compassionate Use, Expanded Access, Legislation, Bill, House, Andrea Sloan