Search Results for Legislation

Showing 1 – 25  of 170

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

New Maryland Law to Restrict Generic Drug Price Increases By Zachary Brennan - Published 30 May 2017

A new Maryland law to keep generic drug prices from increasing by too much goes a step further than price transparency bills and laws in other states, but it’s leaving some with more questions about its broader impact.

Categories: News, US, Biologics and biotechnology, Business Skills, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug prices, state drug price legislation, drug price increases, Nevada insulin

Maryland House Passes Bill on Price Gouging of Generic Drugs By Zachary Brennan - Published 21 March 2017

Late Monday, Maryland’s House of Delegates signed off on a bill seeking to prohibit companies from overcharging for generic drugs.

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

Tags: price gouging, pharmaceutical price legislation, Maryland drug price gouging

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

House to Pass Revamped 21st Century Cures Bill By Zachary Brennan - Published 30 November 2016

The US House of Representatives on Wednesday is poised to pass a wide-ranging bill that will overhaul certain aspects of the US Food and Drug Administration (FDA) and provide the agency with more funding.

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

Tags: 21st Century Cures, #CuresNow, Cancer Moonshot, FDA legislation, lame duck session

A Summary of 10 Years of Paediatric Legislation in the European Union By Hans van Bronswijk, MD, PhD - Published 28 November 2016

This article summarizes 10 years of experience with paediatric regulations in the EU.

Categories: Features, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs, Submission and registration

Tags: Paediatric Legislation, Paediatric Investigation Plan, Paediatric Committee, (PDCO)

European Regulatory Roundup: UK Advances Bill to Stop Price Spikes on Generic Drugs (27 October 2016) By Nick Paul Taylor - Published 27 October 2016

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

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

Tags: drug price increases, UK pharmaceutical legislation, Swissmedic

European Commission to Overhaul Concept of ‘Similar’ Medicines Within Context of Orphan Legislation By Zachary Brennan - Published 29 July 2016

The European Commission on Friday proposed to review the concept of “similar medicinal products” in the context of its orphan legislation as part of a wider effort to adapt the text to technical progress.

Categories: News, Europe, EC, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Government affairs, Orphan products

Tags: orphan drug legislation, European Commission, gene therapy, ATMP

Brexit Creating a Period of Uncertainty for EU, UK Drug and Device Regulators By Zachary Brennan - Published 28 June 2016

The fallout from the UK referendum is continuing to create strife among the ranks of the European Medicines Agency (EMA), though a top EMA official told the DIA annual conference on Tuesday in Philadelphia that business at the agency will carry on as usual as negotiations continue.

Categories: News, Europe, EMA, FDA, MHRA, Drugs, Government affairs, Medical Devices, Research and development

Tags: Brexit, UK drug legislation, UK drug regulations, DIA conference 2016

New Senate Bill Would Change the Way FDA Regulates Devices By Zachary Brennan - Published 22 March 2016

A new Senate bill introduced this week would, among other things, allow the US Food and Drug Administration (FDA) to no longer require premarket submissions for some low-risk Class I and II medical devices.

Categories: News, US, CDRH, Government affairs, Medical Devices, Postmarket surveillance, Quality

Tags: device legislation, low-risk medical devices, device classification, postmarket device tracking

New Senate Bill Looks to Help FDA Attract Talent By Zachary Brennan - Published 17 March 2016

The Senate’s response to the House-passed 21st Century Cures bill is slowly shifting into a series of bills, the latest of which would seek to help the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) attract top new employees.

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

Tags: FDA hiring, Regan-Udall, FDA legislation

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

European Regulatory Roundup: UK Plans Off-Label, Experimental Drug Database (4 February 2016) By Nick Paul Taylor - Published 04 February 2016

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

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Clinical, Drugs, Government affairs, Veterinary products

Tags: database of off-label treatments, UK legislation, pandemic vaccines, CRISPR

End in Sight for Discussions Over New EU Medical Device Regulations By Michael Mezher - Published 28 October 2015

New EU regulations for medical devices and in vitro diagnostics (IVDs) could be adopted as early as next year, a European Commission representative told attendees at RAPS' Regulatory Convergence on Tuesday.

Categories: News, Europe, EC, Government affairs, Medical Devices, Postmarket surveillance, Regulatory strategy

Tags: EU Medical Device Legislation, single-use device reprocessing

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

Bipartisan Group of Senators Introduces Bill to Speed Development of Rare Disease Drugs By Zachary Brennan - Published 16 September 2015

A new bipartisan bill aims to help accelerate the development of targeted drugs to treat rare diseases, including Duchenne muscular dystrophy, cystic fibrosis, some cancers and other genetic diseases.

Categories: News, US, FDA, Clinical, Drugs, Government affairs, Orphan products, Regulatory strategy

Tags: rare disease drug development, orphan drugs, OOPD, FDA, bipartisan 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

Congress Eyes Wider Use of Third-Party Medical Device Assessments By Alexander Gaffney, RAC - Published 13 May 2015

A revised version of the 21st Century Cures Act, a bill being considered by the House Energy and Commerce (E&C) Committee, would allow medical device manufacturers to leverage third-party auditors to assess the state of their quality manufacturing systems.

Categories: News, US, CDRH, Audit, Medical Devices, Quality

Tags: 21st Century Cures Act, 21st Century Cures Initiative, Congress, Bill, Legislation, Third-Party Audits, third-party quality system assessment

Marketing Exclusivity Provisions for Rare Disease Drugs Back in 21st Century Cures Bill By Alexander Gaffney, RAC - Published 13 May 2015

An updated draft of the House Energy and Commerce (E&C) Committee's 21st Century Cures Act has reintroduced a provision which would extend marketing exclusivity for some drugs repurposed to treat rare diseases or conditions by six months.

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

Tags: Congress, 21st Century Cures Initiative, 21st Century Cures Act, Legislation, Bill, Energy and Commerce Committee, E&C

Legislation Calls for FDA to Ensure Expedited Drugs are Safe for Women By Alexander Gaffney, RAC - Published 06 May 2015

New legislation introduced last week in the House of Representatives would require greater gender equity in some clinical trials overseen by the US Food and Drug Administration (FDA).

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

Tags: Legislation, Congress, Women

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

Senators Seek to Expedite FDA Review of 'Breakthrough' Medical Devices By Alexander Gaffney, RAC - Published 27 April 2015

Medical device manufacturers may soon benefit from an expedited review pathway now only afforded to "breakthrough" pharmaceutical products if a bipartisan trio of US legislators have their way.

Categories: News, US, CDRH, Medical Devices

Tags: Breakthrough Therapy, Breakthrough Device, Breakthrough Technology, Advancing Breakthrough Devices for Patients Act, Congress, Senate, Legislation, Bill

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

Does FDA Need New Authority to Regulate Complex Generic Drugs? By Alexander Gaffney, RAC - Published 01 April 2015

New legislation introduced in the US House of Representatives seeks a government investigation into the US Food and Drug Administration's (FDA) review of complex generic pharmaceuticals to consider whether the agency is in need of new regulatory authority.

Categories: News, US, CDER, Generic drugs

Tags: Bill, Congress, Legislation, Generic Complex Drugs Safety and Effectiveness for Patients Act, Nonbiologic Complex Drugs, Complex Generic Drugs

Bill Wants Drugs Approved in Europe to be Available More Quickly to US Patients By Alexander Gaffney, RAC - Published 20 March 2015

New legislation introduced in the US House of Representatives this week would require the US Food and Drug Administration (FDA) to expedite the review and approval of pharmaceutical products already approved in Europe.

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

Tags: NME, NAS, Bill, Congress, Legislation, Speeding Access to Already Approved Pharmaceutical Act