Search Results for Congress

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Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA By Zachary Brennan - Published 28 November 2016

Lingering for more than two years, the revamped 21st Century Cures bill, unveiled in late November, has now been approved by the House and Senate and President Barack Obama has said he will sign it.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Compliance, Drugs, Government affairs, Human cell and tissue, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: 21st Century Cures, drug regulations, Congress and medical innovation, NIH, FDA innovation, Cures Now

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

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

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

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

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

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

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

Senator Wants Companies Who Break FDA Regulations to Help Fund NIH By Alexander Gaffney, RAC - Published 23 January 2015

US Sen. Elizabeth Warren (D-MA) has unveiled plans to introduce new legislation she says will require pharmaceutical companies found guilty of regulatory and legal non-compliance to pay large fines, all in the hopes of providing a new funding stream to the National Institutes of Health (NIH).

Categories: News, US, FDA, Advertising and Promotion, Biologics and biotechnology, Compliance, Drugs, Ethics

Tags: Elizabeth Warren, NIH, National Institutes of Health, Regulatory Noncompliance, Swear Jar, Congress, Senate, Legislation, Medical Innovation Act

Legislators to Obama: Help us in Effort to Reform FDA Regulation By Alexander Gaffney, RAC - Published 20 January 2015

For months, legislators on the House Energy and Commerce (E&C) Committee have been working with a large group of stakeholders in the hopes of developing a series of reforms to the way the US Food and Drug Administration (FDA) approves new drugs and medical devices.

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

Tags: E&C, Barack Obama, Energy and Commerce Committee, Congress, Legislation, 21st Century Cures

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

Obama Signs Special Ebola Incentive Program Into Law By Alexander Gaffney, RAC - Published 18 December 2014

President Barack Obama has signed a new bill into law allowing any pharmaceutical or biotechnology company that successfully develops a product to treat the Ebola virus to obtain a special voucher potentially worth millions—and even billions—of dollars.

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

Tags: Ebola, Priority Review Voucher, PRV, Neglected Tropical Disease Priority Review Voucher, Bill, Legislation, Congress, President Barack Obama, Adding Ebola to the FDA Priority Review Voucher Program Act

Anabolic Steroid Regulation Bill Awaits President's Signature By Alexander Gaffney, RAC - Published 15 December 2014

New legislation set to be signed into law by US President Barack Obama would ban dozens of active ingredients now used in the production of anabolic steroids, and also make it easier for federal authorities to prohibit the production of similar products.

Categories: News, US, Drugs, Labeling, Nutritional and dietary supplements, Submission and registration

Tags: Legislation, Bill, Congress, Anabolic Steroid, Designer Anabolic Steroid Control Act, (DASCA), DEA

How Should Diagnostic Tests be Regulated? Congress Wants to Know By Alexander Gaffney, RAC - Published 12 December 2014

A new white paper published by the House Energy and Commerce Committee is calling for feedback on the US Food and Drug Administration's (FDA) proposal to regulate laboratory developed tests (LDTs) more similarly to how they regulate in vitro diagnostics.

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

Tags: LDT, Lab Developed Tests, Laboratory Developed Tests, Congress, Energy and Commerce Committee, E&C, Whitepaper, White Paper

Senators Call for 15 Years of Marketing Exclusivity for Some New Drugs Published 12 December 2014

Two US senators have proposed new legislation that would grant an unprecedented 15 years of marketing exclusivity to certain types of pharmaceutical and biopharmaceutical products.

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

Tags: MODDERN Cures Act, Marketing Exclusivity, Senate, Congress, Bill, Legislation, Dormant Therapies Act

Bill Seeks Creation of New Pathway for Antibiotic Drug Approvals By Alexander Gaffney, RAC - Published 11 December 2014

New legislation would allow the US Food and Drug Administration (FDA) to approve some antibiotics through a special "limited use" regulatory pathway, all in the hope of bringing more antibiotics to market to help fight antibiotic-resistant bacteria.

Categories: News, US, FDA, Clinical, Prescription drugs, Submission and registration

Tags: Antibiotics, Legislation, Bill, Limited Population Pathway, Promise for Antibiotics and Therapeutics for Health (PATH) Act, Congress, Senate