Search Results for Ebola

Showing 1 – 25  of 38

FDA Offers 2016 Report on Medical Countermeasure Activities By Zachary Brennan - Published 20 March 2017

As part of efforts to protect the US against chemical, biological, radiological, and nuclear (CBRN) threats, the US Food and Drug Administration (FDA) approved seven new treatments and 21 new devices in FY 2016, according to a program update on medical countermeasure (MCM) activities.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Quality

Tags: medical countermeasures, Ebola, Zika, flu vaccine

Approval of Anthrax Vaccine Under FDA’s Animal Rule is a Step Forward, Researchers Argue By Zachary Brennan - Published 25 August 2016

Although the US Food and Drug Administration’s (FDA) 2015 approval of the vaccine BioThrax for postexposure prophylaxis (PEP) for inhalational anthrax wasn’t the first approval under the rarely used Animal Rule, researchers in Nature explained on Thursday why it is a “significant step forward” in the approval of new vaccines and other medical countermeasures under the pathway.

Categories: News, Canada, Europe, US, FDA, Biologics and biotechnology, Clinical, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: Animal Rule, Nature, Accelerated Approval, Ebola, Anthrax, medical countermeasures

EMA Adds Four New Drugs to PRIME Scheme By Michael Mezher - Published 27 July 2016

The European Medicines Agency (EMA) has granted four new drugs eligibility to its PRIority MEdicines (PRIME) scheme, bringing the total number of drugs accepted to the program to eight.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Preclinical, Regulatory strategy, Research and development, Submission and registration

Tags: PRIME scheme, PRIority MEdicines, Novartis, Merck, Adaptimmune, DNATrix, CTL019, Ebola Vaccine, NY-ESO-1c259T, DNX-2401

Congress Considers Priority Review Vouchers for Medical Countermeasures By Michael Mezher - Published 12 February 2016

Members of the House Energy and Commerce Oversight and Investigations subcommittee were briefed on recommendations at a hearing Friday for improving the nation's biodefence strategy against natural and man-made threats.

Categories: News, Latin America and Caribbean, US, FDA, Biologics and biotechnology, In vitro diagnostics, Regulatory strategy, Research and development, Submission and registration

Tags: Biodefense, Blue Ribbon Study Panel on Biodefense, Medical Countermeasures, MCMs, Priority Review Voucher, PRV, Zika Virus, Ebola, Bioterrorism

FDA and EMA Share Perspectives on Evaluating Ebola Treatments By Michael Mezher - Published 18 January 2016

Officials from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have shared their perspectives on evaluating treatments for Ebola in two articles appearing in Clinical Trials.

Categories: News, Africa, Europe, US, EMA, FDA, WHO, Biologics and biotechnology, Clinical, Drugs, Ethics, Postmarket surveillance, Preclinical, Regulatory strategy, Research and development, Submission and registration

Tags: Ebola, Emergency Use Authorization, Animal Rule, Conditional marketing authorisation, Accelerated Approval

FDA Offers Guidance for Blood Establishments During Ebola Outbreaks By Michael Mezher - Published 02 December 2015

The US Food and Drug Administration (FDA) has released new recommendations for blood establishments to implement additional screening measures during Ebola virus outbreaks.

Categories: News, Africa, US, CBER, WHO, Biologics and biotechnology, Blood, In vitro diagnostics, Medical Devices, Orphan products

Tags: Ebola

Ebola—Expedited Pathways for Drugs and Vaccines in Europe: The EMA Perspective By Ralf D. Hess, MS, PhD, Mark Mathieu and Dieter Russmann, MD - Published 22 July 2015

This article discusses the European Medicines Agency (EMA) facilitated expedited pathways for drug and vaccine approval to enable  fast access to market to fight emerging diseases, such as Ebola.

Categories: Articles, Features, Africa, Europe, EMA, Prescription drugs

Tags: Ebola, vaccine, vaccines, European Medicines Agency, EMA

Group Sues FDA, Seeking Access to Ebola Information By Alexander Gaffney, RAC - Published 10 June 2015

A battle over regulatory documents has led a libertarian-leaning think tank, The Goldwater Institute, to sue the US Food and Drug Administration (FDA) in the hopes of compelling the agency to hand over information related to how several US citizens received drugs to treat the Ebola virus.

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

Tags: The Goldwater Institute, Ebola, FOIA, Lawsuit

UK Prime Minister Calls for Greater Clinical Trial Transparency in Emergencies By Michael Mezher - Published 08 June 2015

In response to the shortfalls in the international response to the Ebola outbreak, UK Prime Minister David Cameron is proposing a plan to boost research and transparency in the hopes of better confronting future public health crises.

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

Tags: Ebola, G7 summit, Clinical trial transparency

Public Health Groups Propose Global Drug Innovation Fund By Michael Mezher - Published 13 May 2015

Two health advocacy groups, Médecins Sans Frontières (MSF) and the Drugs for Neglected Diseases initiative (DNDi) are urging public health authorities to create a global fund to tackle what they call "deadly gaps in innovation."

Categories: News, WHO, Biologics and biotechnology, Drugs, Research and development

Tags: Médecins Sans Frontières, MSF, Drugs for Neglected Diseases initiative, DNDi, Ebola, antimicrobial resistance, AMR, neglected tropical diseases, NTD

HHS Says it Will Shield Maker of Ebola Therapy ZMapp from Legal Liability By Alexander Gaffney, RAC - Published 23 April 2015

The US Department of Health and Human Services (DHHS) says it will shield the manufacturer of the investigational Ebola virus treatment ZMapp from legal liability under a federal law intended to incentivize the development of new medical products for medical emergencies.

Categories: News, US, FDA, Biologics and biotechnology

Tags: Ebola, ZMapp, HHS, PAHPRA, PREP Act, Liability

In Fight Against Ebola, Device Company Seeks FDA Approval Through Rarely Used Pathway By Alexander Gaffney, RAC - Published 10 April 2015

In the battle against the Ebola virus, perhaps no weapons have been as sought after as new treatments and diagnostic products to help keep the virus in check and patients safe from harm. But since the start of the outbreak in 2014, one regulatory standard has been an elusive goal for these medical products: Approval. To date, no product has received the full approval of the US Food and Drug Administration (FDA). Now one company is hoping to change that.

Categories: News, US, CDRH, Medical Devices, Regulatory strategy, Submission and registration

Tags: Ebola, HUD, HDE, Humanitarian Use Device, Humanitarian Device Exemption

An Argument for Emergency Authorization During Public Health Crises By Michael Mezher - Published 09 March 2015

When a public health crisis like Ebola emerges, public health officials need the flexibility to respond quickly and effectively. But as a new paper in the journal Public Library of Science - Medicine (PLoS Medicine) argues, many countries currently have in place regulatory hurdles which would delay access to experimental new emergency treatments during such crises.

Categories: News, Africa, Europe, US, EMA, FDA, WHO, Ethics, Regulatory strategy, Submission and registration

Tags: Ebola, Emergency Use Authorization, Compassionate Use

WHO Gives OK to First Rapid-Result Ebola Diagnostic By Michael Mezher - Published 23 February 2015

The World Health Organization (WHO) has approved the first rapid-result diagnostic test for detecting Ebola.

Categories: News, Africa, WHO, In vitro diagnostics, Medical Devices

Tags: Ebola, ReEBOV, Emergency Use Assessment and Listing, EUAL

FDA's CBER Announces Plans to Release Guidances on Gay Blood Ban, Ebola and More By Alexander Gaffney, RAC - Published 26 January 2015

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) plans to release nearly a dozen guidance documents this year, including a massively anticipated document outlining planned changes to its "donor deferral policy" that now prevents most homosexual men from donating blood.

Categories: News, US, CBER, Biologics and biotechnology, Blood

Tags: Guidance Agenda, CBER Guidance Agenda, Ebola, Blood Ban, Donor Deferral Policy, Guidance, Draft Guidance, Final Guidance

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

Applying Ethics to Conflicting Healthcare Philosophies: The Ebola Example and the RAPS Ethics Code By Zerela Henry, CHC, and Joy Frestedt, PhD, CCTI, RAC, FRAPS - Published 08 December 2014

How regulatory professionals can apply the RAPS Code of Ethics to current and future endemic disease outbreaks characterized by a rapidly developing healthcare situation and quickly evolving knowledge base regarding prevention, treatment and potential cures.

Categories: Features, Africa, Drugs, Ethics

Tags: Ebola, emerging diseases, treatments, prevention, potential cures

US Government Immunizes Future Manufacturers of Ebola Vaccines from Legal Liability By Alexander Gaffney, RAC - Published 09 December 2014

The US Department of Health and Human Services (DHHS) is providing a gift to manufacturers of prospective vaccines meant to protect patients against the Ebola virus: Protection from legal liability.

Categories: News, US, Biologics and biotechnology

Tags: Ebola, DHHS, Vaccine, Legal Liability

Federal Commission Prepares to Weigh in on Ethics of Testing Ebola Treatments By Alexander Gaffney, RAC - Published 09 December 2014

President Barack Obama's bioethics commission is preparing to weigh in on whether the US Food and Drug Administration (FDA) should require manufacturers of investigational products intended to either treat or prevent the Ebola virus to run clinical trials with placebo controls.

Categories: News, US, FDA, Clinical, Ethics

Tags: Ebola, Ethics, Presidential Commission for the Study of Bioethical Issues

Legislation to Increase Regulatory Incentives to Fight Ebola Awaits Obama's Signature By Alexander Gaffney, RAC - Published 04 December 2014

The US House has quickly passed legislation making changes to the Neglected Tropical Disease Priority Review Voucher (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular to those developing new treatments for the Ebola virus.

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

Tags: Ebola, PRV, Priority Review Voucher, Neglected Tropical Disease Priority Review Voucher, Bill, Legislation, House, Congress

Ebola Voucher Bill Clears Senate, on Course to Become Law By Alexander Gaffney, RAC - Published 03 December 2014

The US Senate has passed legislation that would overhaul the Neglected Tropical Disease Priority Review Voucher (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular those developing new treatments for the Ebola virus.

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

Tags: Voucher, Ebola, Neglected Tropical Disease Priority Review Voucher, Priority Review Voucher, Tropical Disease Priority Review Voucher, Senate, Legislation, Adding Ebola to the FDA Priority Review Voucher Program Act, Bill

US Congress Pushes Ahead With Legislation to Reform FDA Voucher Program By Alexander Gaffney, RAC - Published 20 November 2014

Both the US House of Representatives and Senate are moving forward with identical pieces of legislation meant to overhaul the Neglected Tropical Disease Priority Review Voucher (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular those developing new treatments for the Ebola virus.

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

Tags: PRV, Priority Review Voucher, Congress, Adding Ebola to the FDA Priority Review Voucher Program Act, Ebola, Neglected Tropical Disease Priority Review Voucher

Canada Launches Ebola Vaccine Trial By Louise Zornoza, RegLink News - Published 17 November 2014

The Canadian Institutes of Health Research (CIHR) and the Public Health Agency of Canada (PHAC) have provided funding for a Phase I clinical trial using Canada’s Ebola vaccine (VSV-EBOV), Canada's Minister of Health, Rona Ambrose, announced last week. 

Categories: News, Canada, Health Canada, Biologics and biotechnology, Clinical

Tags: RegLink, CIRN, Ebola, Vaccine, Ebola Vaccine, Canadian Institutes of Health Research, Public Health Agency of Canada

FDA Authorizes Sixth Device to Help in Fight Against Ebola By Alexander Gaffney, RAC - Published 14 November 2014

The US Food and Drug Administration (FDA) has once again given its blessing to a new diagnostic tool meant to help identify treatments for Ebola—the sixth time it has used its emergency authority to do so in the last four months.

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

Tags: Ebola, EUA, Emergency Use Authorization, Diagnostic

US Senate Unveils Major Changes to FDA Program in Hopes of Fighting Ebola By Alexander Gaffney, RAC - Published 12 November 2014

Legislators in the US Senate have unveiled a new piece of legislation meant to incentivize companies to go after the Ebola virus by making critical and long-sought changes to a US Food and Drug Administration (FDA) regulatory program.

Categories: News, US, FDA, Drugs

Tags: Ebola, Priority Review Voucher System, FDAAA, Priority Review, Legislation, Congress, Senate, HELP Committee, Tropical Disease Priority Review Voucher