Search Results for Antibiotics

Showing 1 – 25  of 44

Patients Not Always Informed of Study's Purpose in Noninferiority Trials By Michael Mezher - Published 23 August 2017

A study published in JAMA Internal Medicine this week finds that patients participating in noninferiority trials for antibiotics are not always accurately informed of the purpose of the study, based on an analysis of informed consent forms.

Categories: News, EMA, FDA, Clinical, Drugs, Ethics

Tags: Noninferiority, Superiority, Antibiotics, Clinical Trials, Informed Consent

European Regulatory Roundup: ENVI Urges EC to Exclude Healthcare From Regulation of Professions (15 June 2017) By Nick Paul Taylor - Published 15 June 2017

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

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Medical Devices

Tags: European Regulatory Roundup, ENVI, antibiotics, PRAC

FDA, EMA and PMDA Seek Antimicrobial Clinical Study Regulation Harmonization By Zachary Brennan - Published 26 May 2017

For the second time in seven months, the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) met in late April to discuss their approaches for evaluating antimicrobial agents, with the aim of identifying areas for convergence.

Categories: News, Asia, Europe, US, EMA, FDA, PMDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: antimicrobial resistance, antibiotic resistance, new antibiotics

European Regulatory Roundup: EMA to Revise Guideline on Quality of Inhaled Medical Products (30 March 2017) By Nick Paul Taylor - Published 30 March 2017

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

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Regulatory intelligence, Submission and registration

Tags: EMA guideline, antibiotics, animal health

CTTI Offers Recommendations for Pediatric Clinical Trials for Antibiotics By Michael Mezher - Published 16 February 2017

The Clinical Trials Transformation Initiative (CTTI) has released a set of recommendations it says will improve the use of antibiotics in children.

Categories: News, EMA, FDA, Clinical, Drugs

Tags: Pediatric clinical trials, Antibacterial, Antibiotics, CTTI, Clinical Trials Transformation Initiative

European Regulatory Roundup: UK to Increase Regulatory Oversight of Antibiotics (22 September 2016) By Nick Paul Taylor - Published 22 September 2016

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

Categories: News, EC, EMA, MHRA, Biologics and biotechnology, Drugs

Tags: EU, antibiotics, HTA, marketing authorisation

EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection By Zachary Brennan - Published 19 August 2016

A statement of noncompliance released by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday effectively bans in the EU medicinal products considered non-critical to public health from Pfizer's Irungattukottai, India-based site following an inspection with four regulators.

Categories: News, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, MHRA, TGA, Active pharmaceutical ingredients, Drugs, Manufacturing, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: GMP inspection, Pfizer, India drug manufacturing, antibiotics manufacturing

Woodcock: Antibiotics Pipeline is 'Fragile and Weak' By Michael Mezher - Published 14 June 2016

At a congressional hearing in Washington, DC on Tuesday, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that current incentives are not enough to overcome the challenges of developing new drugs to fight bacterial infections.

Categories: News, US, FDA, Clinical, Drugs, In vitro diagnostics, Preclinical, Research and development

Tags: Antimicrobial Resistance, AMR, Antibiotics, Janet Woodcock, Energy & Commerce Committee, GAIN Act, ADAPT Act

European Regulatory Roundup: Parliament Seeks More Responsible Use of Antibiotics (10 March 2016) By Nick Paul Taylor - Published 10 March 2016

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

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy, Veterinary products

Tags: European Regulatory Roundup, EU medical news, antibiotics, monoclonal antibodies

Health Canada to Require Precautionary Statements in Antimicrobial Labels By Zachary Brennan - Published 16 November 2015

As part of efforts to encourage the more prudent prescribing and use of antimicrobials, Health Canada on Monday announced it will now require the inclusion of precautionary statements in antimicrobial product labelling.

Categories: News, Canada, Health Canada, Active pharmaceutical ingredients, Crisis management, Drugs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: Health Canada, antimicrobials, antibiotics, superbugs, drug labels, labeling

European Regulatory Roundup: Dutch Regulator Revamps Drug Nomenclature Policy (22 October 2015) By Nick Paul Taylor - Published 22 October 2015

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

Categories: News, Europe, EMA, ICH, Drugs, Due Diligence, Postmarket surveillance, Quality, Regulatory intelligence, Research and development, Veterinary products

Tags: EMA, MEB, CHMP, veterinary antibiotics, ICH, Pradaxa

EMA Draft Guidance Seeks to Speed New Antibiotics Development By Zachary Brennan - Published 28 September 2015

The European Medicines Agency (EMA) is seeking comment on a new draft guideline that could help industry use of pharmacokinetics (PK) and pharmacodynamics (PD) analyses to speed the development of novel antibiotics that target multidrug-resistant bacteria and address unmet medical needs.

Categories: News, Europe, EMA, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: Netherlands, MEB, EMA, PK, PD, antibiotics, bacteria

FDA Finalizes Policy Meant to Limit Use of Antibiotics in Farm Animals By Alexander Gaffney, RAC - Published 02 June 2015

The US Food and Drug Administration (FDA) has released a long-anticipated final rule meant to limit the use of antibiotics in food-producing animals in order to limit the spread of antibiotic-resistant bacteria.

Categories: News, US, FDA, Distribution, Veterinary products

Tags: VFD, Veterinary Feed Directive, Antibiotics, Antimicrobials

Global Efforts to Combat Antimicrobial Resistance 'Lacking,' WHO Report Finds By Michael Mezher - Published 29 April 2015

The World Health Organization (WHO) has completed the first global assessment of national strategies to counter the rise of antimicrobial resistance (AMR). Only a quarter to countries had plans in place to limit the use of antimicrobials, leaving "major gaps" in the struggle against AMR in every region of the world.

Categories: News, WHO, Drugs

Tags: WHO, Antimicrobial Resistance, Antibiotics, AMR

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

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

As US Falters in Fight Against Antibiotics Over-Prescribing, EU Makes Progress By Alexander Gaffney, RAC - Published 15 October 2014

The European Union seems to be making substantial strides in something the US thus far has been unable to do: reducing the use of antibiotics in food-producing animals.

Categories: News, Europe, US, EC, EMA, FDA, Drugs, Veterinary products

Tags: Antimicrobials, Antibiotics, Antibiotic, Antibiotic Prescribing

US Launches New Antibiotics Strategy, Calls for New Regulatory Efforts and Incentives By Alexander Gaffney, RAC - Published 19 September 2014

A new federal strategy aimed at combatting antibiotic resistance calls for the creation of a "robust pipeline of new antibiotics" and new "comprehensive monitoring" systems to track resistance trends.

Categories: News, US, CDER, Drugs, Research and development

Tags: Antibiotics, Antibiotic Resistance, PCAST, Executive Order, Microbial Resistance, Special Medical Use

PhRMA to FDA: Antibiotic Guidance Focuses too Much on Superiority By Alexander Gaffney, RF News Editor - Published 16 December 2013

Categories: US, FDA

Tags: antibiotics, PhRMA, Antibacterial, Antimicrobials, Latest News, draft guidance

FDA Doubles Down on Voluntary Approach to Limiting Use of Antibiotics in Food-Producing Animals By Alexander Gaffney, RF News Editor - Published 11 December 2013

Categories: US, FDA

Tags: Antimicrobial Resistance, antibiotics

Extensive New Guidance Explains FDA's Recommendations for Streamlined Antibiotic Development By Alexander Gaffney, RF News Editor - Published 01 July 2013

Categories: US, FDA

Tags: Antibacterials, antibiotics, draft guidance

FDA Looks to Spur Antibiotic Drug Development by Adding 18 Pathogens to Incentives List By Alexander Gaffney, RF News Editor - Published 11 June 2013

Categories: US, FDA

Tags: GAIN Act, antibiotics

EMA Looks to Cut Down on Antibiotic Resistance through New Efficacy Guidelines By Alexander Gaffney, RF News Editor - Published 29 May 2013

Categories: EMA

Tags: Antimicrobial, antibiotics, Draft Guideline, Latest News, guideline, EU

Pharmaceutical Industry to FDA: Build Flexibility into GAIN Act By Alexander Gaffney, RF News Editor - Published 17 May 2013

Categories: US, FDA

Tags: GAIN Act, antibiotics

Group Sues FDA, Seeking 'Confidential Information' About Antibiotic Prescribing Data By Alexander Gaffney, RF News Editor - Published 06 December 2012

Tags: Sales Data, AGDUFA, ADUFA, antibiotics, Antimicrobials, data