Search Results for Bill

Showing 1 – 25  of 111

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

‘FAST’ Generics Act Seeks to Thwart Abuse of FDA Safety Programs By Zachary Brennan - Published 10 April 2017

A bipartisan House bill introduced on Friday seeks to stop pharmaceutical companies from blocking generic competitors by abusing US Food and Drug Administration (FDA) safety programs.

Categories: News, US, FDA, Distribution, Generic drugs, Government affairs

Tags: generic drug bill, pay for delay, REMS, delaying generic drug entry

Democrats Revive Canada Drug Import Bill as Safety Questions Linger By Zachary Brennan - Published 28 February 2017

Sens. Bernie Sanders (D-VT) and several colleagues who previously opposed such a measure, Cory Booker (D-NJ), Bob Casey (D-PA), Martin Heinrich (D-NM), Angus King (I-ME), alongside Reps. Elijah Cummings (D-MD) and Lloyd Doggett (D-TX) on Tuesday revived legislation lingering for more than a decade to allow the importation of medicines from Canada and other countries to help lower US drug prices.

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

Tags: Canada pharmaceutical imports, Bernie Sanders, drug costs, Rx import bill

Maryland Goes a Step Further to Rein in Drug Price Spikes By Zachary Brennan - Published 27 February 2017

A Maryland bill to shine more light on prescription drug prices takes the standard for state transparency efforts a step further by not only requiring pharmaceutical companies to offer a peek into their innerworkings but requires annual reports to be audited by third parties.

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

Tags: drug price transparency, Maryland drug price bill, drug transparency

Cassidy Says Obamacare Repeal Will Not Repeal Biosimilars Approval Pathway By Zachary Brennan - Published 07 December 2016

Sen. Bill Cassidy (R-LA) told attendees of a policy briefing at the Newseum on Wednesday that when Republicans repeal Obamacare, which is expected to occur soon after President-elect Donald Trump takes office, the approval pathway for biosimilars that was created thanks to that law will not go away.

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

Tags: Obamacare, ACA, biosimilars, Bill Cassidy

A ‘Cures’ Revival? Congress Looks to Lame Duck Session to Pass Bill Overhauling FDA, NIH By Zachary Brennan - Published 31 October 2016

With the election just eight days away, House and Senate Republicans are working hard to re-shape a wide-ranging bill lingering for more than two years that would overhaul the way the US Food and Drug Administration (FDA) reviews medical devices and significantly increase (to the tune of almost $9 billion over five years) funding for the National Institutes of Health (NIH), among other major changes.

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

Tags: Cures, 21st Century Cures, Cures bill, biomedical innovation bill, NIH funding

Senate Democrats Call for FDA, NIH Funding Boost as Other Bills Emerge By Zachary Brennan - Published 04 March 2016

Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) on Thursday introduced a bill that would provide $5 billion per year in new funding for the Food and Drug Administration (FDA) and National Institutes of Health (NIH) as other legislation impacting FDA will be discussed and voted on in the coming week.

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

Tags: opioids, device regulation bill, pharmaceutical bill, FDA funding

Congressional Spending Deal Offers $132m More for FDA in 2016 By Zachary Brennan - Published 16 December 2015

As House and Senate lawmakers race to approve a bill to fund the US government for 2016, the US Food and Drug Administration (FDA) should see a slight bump in discretionary funding of $132 million over last year.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Crisis management, Drugs, Government affairs, Manufacturing, Project management, Reimbursement

Tags: omnibus bill. FDA appropriations, Congress spending, FDA budget, FY2016 FDA

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

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

Tougher FDA Approval Process for Opioids Sought by Congress By Alexander Gaffney, RAC - Published 16 April 2015

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA).

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

Tags: Opioids, Zohydro, Bill, Legislators, Senators, Senate, FDA Accountability for Public Safety Act

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

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

Leader Sought for FDA's Influential Office of Device Evaluation By Alexander Gaffney, RAC - Published 16 March 2015

The US Food and Drug Administration (FDA) is seeking a permanent leader for its medical device-focused Office of Device Evaluation (ODE), the division responsible for reviewing nearly all medical devices marketed in the US.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices

Tags: ODE, Office of Device Evaluation, Bill Maisel, ODE Director

Senators Call for New Limits on 'Medically Important' Antibiotics By Alexander Gaffney, RAC - Published 06 March 2015

A new bill introduced this week in the US Senate would restrict the use of "medically important" antibiotics in agriculture in the hopes of reducing the risk of bacteria developing resistance to those drugs.

Categories: News, US, FDA, Drugs, Labeling, Veterinary products

Tags: Legislation, Bill, Senate, Antibiotics, Antimicrobials

Legislators Want to Exempt Much of FDA's Funding from Future Budget Cuts By Alexander Gaffney, RAC - Published 26 February 2015

New legislation introduced in Congress would exempt nearly half of the US Food and Drug Administration's (FDA) budget from austerity measures meant to help balance the federal budget.

Categories: News, US, FDA

Tags: User Fees, PDUFA, MDUFA, BsUFA, AGDUFA, ADUFA, GDUFA, Sequester, Sequestration, Bill, Legislation, Congress

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

Will FDA Have to Change its Name? New Bill Takes the 'Food' out of FDA By Alexander Gaffney, RAC - Published 29 January 2015

If a new bill introduced in Congress this week is ultimately passed, the US Food and Drug Administration (FDA) might soon need to change its 85-year-old name—and give up all of its authority to regulate food, including dietary supplements.

Categories: News, US, FDA, Nutritional and dietary supplements

Tags: DSHEA, Dietary Supplement, Food Safety Administration, Bill, Senate, Legislation, Dick Durbin, Food

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

Drug Counterfeiters Could Get Life in Prison Under New Bill By Alexander Gaffney, RAC - Published 06 January 2015

New legislation introduced in the US House of Representatives just prior to the holiday break would amend the Federal Food, Drug and Cosmetic Act (FD&C Act) to increase penalties on the sale or trade of counterfeit pharmaceuticals and also grant the US Food and Drug Administration (FDA) new authority to recall drugs.

Categories: News, US, CDER, Distribution, Drugs, Ethics

Tags: Bill, Legislation, Counterfeit, Adulterated, Misbranded, Counterfeit Drug Enforcement Act