Search Results for NIH

Showing 1 – 25  of 55

HHS Secretary Working With Trump on a Plan to Reduce Drug Prices By Zachary Brennan - Published 29 March 2017

Health and Human Services Secretary Tom Price told a House appropriations subcommittee on Wednesday that his agency is working with President Donald Trump on a plan to bring down the cost of pharmaceutical drugs.

Categories: News, US, FDA, Government affairs

Tags: HHS appropriations, NIH, FDA, budget 2018

21st Century Cures Act Deadlines Approach in March and June By Zachary Brennan - Published 22 February 2017

The massive 21st Century Cures Act, rushed to passage in the waning days of President Barack Obama’s presidency, features a whole host of provisions that will take years for the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) to digest and implement, but it also includes several provisions that must be addressed by 13 March.

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

Tags: 21st Century Cures, Cures Act, NIH and Cures, clinicaltrials.gov, patient experience data and FDA

Leahy Looks to Amend ‘Cures’ Bill as Senate Prepares for Passage By Zachary Brennan - Published 06 December 2016

Sen. Patrick Leahy (D-VT) on Tuesday proposed an amendment to the 21st Century Cures bill that would make it more difficult for brand name drugmakers to halt or delay generic or biosimilar competition.

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

Tags: 21st Century Cures, GPhA, Leahy, generic drugs, NIH

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

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

Final Rule on Clinical Trial Transparency: Will it be Enough to Encourage More Compliance? By Zachary Brennan - Published 16 September 2016

The National Institutes of Health (NIH) on Friday issued a final rule that its leaders said is expected to result in “rapid increases” in the percentage of trials registered and shared via ClinicalTrials.gov, though it remains to be seen if the $10,000 per day penalties from the US Food and Drug Administration (FDA) will be strictly enforced.

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

Tags: clinical trials, final NIH rule, clinical trial transparency, FDA penalties, clinicaltrials.gov

Senate Pushes Work on ‘Cures’ Legislation Back to September By Zachary Brennan - Published 12 July 2016

The Senate’s version of the House-passed 21st Century Cures Act will not be finished until after the Senate’s summer recess, or September at the earliest, Sen. Lamar Alexander (R-TN) said, confirming rumors that the Senate was struggling to reach agreement on the wide-ranging and heavily criticized legislation.

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

Tags: Cures, 21st Century Cures, Alexander, NIH funding

NIH’s Exclusive Licenses to Biotech, Pharma Start-Ups: Lots of Secrecy, Few Successes By Zachary Brennan - Published 10 May 2016

It’s well-known that the National Institutes of Health (NIH) offers billions of dollars in grants to US academic research facilities. What’s less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the hopes of bringing new products to market.

Categories: News, Asia, Europe, US, FDA, Biologics and biotechnology, Clinical, Combination products, Compliance, Drugs, Government affairs, Research and development

Tags: NIH, exclusive start-up licenses, FDA inventions, FDA labs

CDC, NIH 'Working Closely' With FDA on Zika Response By Michael Mezher - Published 10 February 2016

At a Congressional hearing in Washington, DC on Wednesday, officials from the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) say they are working closely with the US Food and Drug Administration (FDA) in their response to the Zika virus.

Categories: News, Latin America and Caribbean, US, FDA, Biologics and biotechnology, Communication, Government affairs, Submission and registration

Tags: Zika virus, Accelerated approval, CDC, NIH, Anthony Fauci, Tom Frieden

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

Lawmakers Urge HHS to Exercise 'March-in' Rights to Fight Higher Drug Costs By Michael Mezher - Published 11 January 2016

A group of 51 lawmakers are calling on the National Institutes of Health (NIH) to issue guidance on when "march-in rights" could be used to bypass patents on drugs developed using federal funding.

Categories: News, US, Biologics and biotechnology, Drugs, Government affairs, Research and development

Tags: March-in rights, Bayh-Dole Act, HHS, NIH, National Institutes of Health, Department of Health and Human Services

NIH Task Force Uncovers Major Issues at Suspended Drug Production Unit By Zachary Brennan - Published 11 December 2015

An internal task force at the National Institutes of Health (NIH) has found “widespread and longstanding” problems at its now-suspended pharmaceutical compounding arm, though the deficiencies were not found to have any direct harm on past or current clinical trial participants.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Compliance, Crisis management, Distribution, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Project management, Quality, Regulatory intelligence, Regulatory strategy

Tags: NIH, NIH drug manufacturing, FDA inspections, PDS, Francis Collins

House Committee Raises 'Grave Concerns' Over Patient Impact of NIH Closure of Drug Production Unit By Zachary Brennan - Published 02 October 2015

The House Energy and Commerce Committee is asking the National Institutes of Health (NIH) for more information on how the temporary closure of its drug manufacturing facility has impacted patients in NIH clinical trials.

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

Tags: Pharmaceutical Development Section, NIH, FDA, CAPs, Upton, Tim Murphy

NIH Plots out Path Forward After Disastrous FDA Inspection By Alexander Gaffney, RAC - Published 22 June 2015

The National Institutes of Health (NIH) says it is working quickly to figure out how to correct major deficiencies uncovered by the US Food and Drug Administration (FDA) last month at one of its drug compounding facilities.

Tags: NIH, National Institutes of Health, Pharmaceutical Development Section, PDS, Corrective Action Plan

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

NIH Calls for Changes to Federal Research Oversight Policies By Alexander Gaffney, RAC - Published 04 December 2014

The National Institutes of Health (NIH) is trying to simplify the oversight of complex, multi-center clinical trials through a new policy promoting the use of a single institutional review board in trials it oversees.

Categories: News, US, Clinical, Ethics

Tags: Central IRB, IRB of Record, Multi-Center Clinical Trials, NIH, National Institutes of Health

How NIH Hopes to Make Running Global Clinical Trials Easier for Everyone By Alexander Gaffney, RAC - Published 29 October 2014

The National Institutes of Health (NIH) has launched a new website meant to make complying with clinical trial regulations around the world substantially easier.

Categories: News, CDSCO, CFDA, FDA, MHRA, Biologics and biotechnology, Clinical, Compliance, Drugs

Tags: ClinRegs, NIH, NIAID, Clinical Trials

A Facebook for Drugs? Regulators Want Help Building Database of What Every Drug Looks Like By Alexander Gaffney, RAC - Published 19 September 2014

A new government project is calling for help from the pharmaceutical industry to make what will be, in effect, a Facebook for drugs.

Categories: News, US, CDER, Drugs

Tags: NIH, C3PI, Drug Imaging, What Drugs Look Like, SPLIMAGE

Leprosy––Not Yet Consigned to History By Max Sherman - Published 19 September 2014

Leprosy has so far eluded efforts to find the final piece of information that might eradicate the age-old disease permanently. Max Sherman writes on the history of leprosy, its etiology and clinical types, treatment and next steps.

Categories: Features, Prescription drugs, Research and development

Tags: Leprosy, skin diseases, etiology, current treatment, new approaches, NIH, NIAID

NIH Wants Safety, Efficacy of Viagra, Epogen and Other Drugs Tested in Children Published 25 August 2014

The National Institutes of Health (NIH) has released a new "Priority List" of pediatric therapeutic areas and medical products it wants the medical community—including the pharmaceutical and biopharmaceutical industries—to focus on.

Categories: Biologics and biotechnology, Prescription drugs, Labeling

Tags: NIH, BPCA, PREA, Priority List, Priority List of Needs of Pediatric Therapeutics, PLNPT, Pediatric, Children, Kids

Legislators Want More Transparency About How Drugs Impact Women By Alexander Gaffney, RAC - Published 19 June 2014

More than a month after pressing the US Food and Drug Administration (FDA) to do more to promote the participation of women and minorities in clinical trials, more than a dozen members of Congress are again pressing government officials to take action on the issue, this time focusing their efforts on clinical data transparency.

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

Tags: Clinical Trials, ClinicalTrials.gov, Legislators, Letter, Women in Clinical Trials, Minorities in Clinical Trials, NIH, National Institutes of Health

NIH Opens up Supplement Labels to Public Researchers, Industry By Alexander Gaffney, RF News Editor - Published 17 June 2013

Categories: US, FDA

Tags: Dietary Supplements, NIH, database

NIH Looks to License out Technologies for Potential HIV Vaccine, Autism Screening Technology By Alexander Gaffney, RF News Editor - Published 28 May 2013

Categories: US

Tags: NCATS, NIH

US Would See Clinical Trials Reporting Transparency Under New Legislation By Alexander Gaffney, RF News Editor - Published 17 May 2013

Categories: US

Tags: ClinicalTrials.gov, Clinical Research, Transparency, NIH, Congress, clinical trials

NIH Looks to Drug Reformulation, Social Media to Combat Opioid Abuse and Misuse By Alexander Gaffney, RF News Editor - Published 16 May 2013

Categories: US

Tags: Painkillers, NIH, pharmaceutical, drug