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Filtering on: "topics preclinical"

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EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research By Zachary Brennan - Published 17 February 2017

The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating the consensus that, when alternatives do not exist, appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for the safety assessment of pharmaceuticals.

Categories: News, Europe, EC, Compliance, Crisis management, Drugs, Ethics, Government affairs, Human cell and tissue, Medical Devices, Preclinical

Tags: animal research, drug safety testing, non-human primates, European Commission Opinion

FDA Issues Long-Awaited Biosimilar Interchangeability Guidance By Michael Mezher - Published 17 January 2017

The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Postmarket surveillance, Preclinical, Submission and registration

Tags: Biosimilar, Biosimilar Interchangeability, Draft Guidance, Switching Study

NCI Launches Formulary to Speed Availability of Investigational Cancer Drugs By Michael Mezher - Published 11 January 2017

The National Cancer Institute (NCI) on Wednesday launched a new effort under the cancer "Moonshot" initiative to speed access to approved and investigational drugs for use in preclinical and clinical cancer studies.

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

Tags: National Cancer Institute, NCI, NCI Formulary, Oncology

EMA Releases Q&A on Exposure Limits and Hazardous Compounds By Zachary Brennan - Published 09 January 2017

The European Medicines Agency (EMA) on Monday released for public consultation a new question and answer document focused on the risk-based prevention of cross contamination in pharmaceutical manufacturing and setting health-based exposure limits for risk identification.

Categories: News, Europe, EMA, Drugs, Preclinical

Tags: hazardous drug compounds, EMA guidance, HBELs

IND Application Fast Facts By Valerie Fauvelle - Published 06 January 2017

This article provides information companies need when filing an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to help make the application process more efficient. It addresses common questions and concerns that develop across multiple companies and multidisciplinary groups.

Categories: Features, US, FDA, Biologics and biotechnology, Clinical, Drugs, Preclinical, Submission and registration

Tags: IND, Investigational New Drug Application

FDA Officials Call for Including Adolescents in Adult Oncology Trials By Michael Mezher - Published 20 December 2016

A team of officials at the US Food and Drug Administration (FDA) are calling for a "culture shift" by drugmakers, regulators and clinical investigators to encourage enrolling more adolescent patients in relevant "adult-type" cancer clinical trials.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Clinical, Drugs, Preclinical

Tags: Pediatric oncology, Adolescent oncology

Lessons Learned from Biosimilar Drug Development By Raymond A. Huml, MS, DVM, RAC, Nigel Rulewski, MD - Published 19 December 2016

This article discusses the emerging US biosimilars market, including critical success factors, safety issues, extrapolation, choice of reference product, partnerships and alliance management, clinical trial recruitment and regulatory and commercial factors. It also describes an accelerated approach to biosimilar clinical development.

Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy

Tags: Biosimilars

FDA Issues Draft Guidance on Physiologically Based Pharmacokinetic Analyses Published 01 December 2016

The US Food and Drug Administration (FDA) on Thursday released a new draft guidance intended to help sponsors report physiologically based pharmacokinetic (PBPK) analyses to the agency in a standardized format.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Preclinical, Submission and registration

Tags: Physiology based pharmacokinetics analyses, PBPK

EMA Highlights Central Nervous System Drug Development Challenges By Michael Mezher - Published 29 November 2016

The European Medicines Agency (EMA) on Tuesday published an analysis highlighting the complexity of developing treatments for central nervous system (CNS) disorders, such as Alzheimer's disease, epilepsy and schizophrenia.

Categories: News, Europe, EMA, Clinical, Drugs, Preclinical, Submission and registration

Tags: Central nervous system disorders, CNS

FDA Revises Guidance on Safety Testing of Drug Metabolites By Zachary Brennan - Published 22 November 2016

The US Food and Drug Administration (FDA) on Tuesday released revised guidance on recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated.

Categories: News, US, FDA, Clinical, Drugs, Government affairs, Preclinical

Tags: drug metabolites, safety testing, nonclinical drug studies

EMA Revises Guideline on First-in-Human Trials By Zachary Brennan - Published 15 November 2016

The European Medicines Agency (EMA), in cooperation with the European Commission and the EU member states, on Tuesday proposed revisions to its 2007 guideline on first-in-human clinical trials as part of an effort to further improve the safety of participants as trial protocols become increasingly complex.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Clinical, Drugs, Preclinical, Quality, Regulatory intelligence, Regulatory strategy

Tags: first in human trials, clinical trial guidance, EU clinical trials, Bial, clinical trial guideline

FDA Withdraws Proposed Rule on Public Disclosure of Info on Unapproved Gene Therapies By Zachary Brennan - Published 10 November 2016

The US Food and Drug Administration (FDA) on Thursday announced it is withdrawing a proposed rule from 2001 that would have required the public disclosure of summaries of safety and effectiveness data, in addition to other information, from pre-market clinical trials of gene therapies and transplanted non-human tissues to humans, known as xenotransplantation.

Categories: News, US, CBER, Biologics and biotechnology, Clinical, Crisis management, Due Diligence, Government affairs, Human cell and tissue, Preclinical, Research and development

Tags: gene therapy, xenotransplantation, BIO, Public Citizen

Australia’s TGA Looks to Mirror US FDA, EMA With Two New Expedited Drug Approval Pathways By Zachary Brennan - Published 31 October 2016

As part of an attempt to catch up with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada, Australia’s Therapeutic Goods Administration (TGA) on Monday released five new consultations for public comment, including one that would forge new priority review and provisional approval pathways.

Categories: News, Oceania, EMA, FDA, Health Canada, TGA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: faster drug approval, accelerated approval, priority review for drugs, international drug regulators

Draft CFDA Guidance on Drug Data Management Practices By Yingying Liu, Siegfried Schmitt - Published 31 October 2016

The China Food and Drug Administration (CFDA) has recently issued a new draft guidance document on data integrity, covering the entire data lifecycle from R&D to commercial production and distribution. This article is a translation of the summary of the draft guidance.

Categories: News, China, CFDA, Clinical, Manufacturing, Preclinical, Research and development

Tags: Data Management

FDA Officials Share Best Practices for Biosimilar Development By Michael Mezher - Published 28 October 2016

With industry interest in biosimilars continuing to grow, top officials at the US Food and Drug Administration (FDA) are urging sponsors to leverage agency advice and follow best practices to ensure the timely success of their biosimilar development programs.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy

Tags: Biosimilars, BsUFA II

US Clears Way for Cuban Drugs By Michael Mezher - Published 14 October 2016

Under the auspices of a new presidential policy directive aimed at promoting greater engagement between the US and Cuba, the US Departments of Treasury and Commerce on Friday announced changes that will clear the way for Cuban-developed drugs to gain approval by the US Food and Drug Administration (FDA).

Categories: News, Latin America and Caribbean, US, FDA, Clinical, Preclinical, Submission and registration

Tags: Cuba

EMA Board Signs Off on New Medicines Web Portal By Zachary Brennan - Published 10 October 2016

The European Medicines Agency’s (EMA) management board on Monday announced that it’s given the go-ahead for a new European medicines web portal, which will look to provide wider access to free, reliable and unbiased information on all medicines authorized in the EU.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: EMA web portal, web portal on medicines, EU website on authorised medicines

FDA, EMA, PMDA Begin Push for New Antibacterials By Michael Mezher - Published 08 September 2016

The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) met at EMA headquarters in London last week to discuss their role in promoting the development of new antibacterial products.

Categories: News, Japan, Europe, US, EMA, FDA, PMDA, Clinical, Drugs, Preclinical, Regulatory strategy, Research and development

Tags: Antimicrobial resistance, AMR

FDA Begins Consultation on Two ICH Guidelines By Michael Mezher - Published 08 September 2016

The US Food and Drug Administration (FDA) has issued two new International Council for Harmonisation (ICH) guidelines for public consultation: one on multi-regional clinical trials (MRCTs) and one on microsampling in study animals.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Clinical, Drugs, Preclinical

Tags: Multi-regional clinical trials, Microsampling, ICH

FDA Finalizes Guidance on Microbiology Data for Antibacterials By Michael Mezher - Published 29 August 2016

The US Food and Drug Administration (FDA) on Friday finalized guidance intended to help drugmakers prepare the data necessary to support the approval of new antibacterial drugs.

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

Tags: Antibacterial, Antimicrobial resistance, Microbiology data, Final guidance

Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program By Zachary Brennan - Published 23 August 2016

The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017.

Categories: News, US, CDRH, Government affairs, Medical Devices, Postmarket surveillance, Preclinical, Project management, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: MDUFA, medical device user fee agreement, AdvaMed, MITA, CLIA, LDTs

FDA Finalizes Two Medical Device Guidelines By Zachary Brennan - Published 23 August 2016

The US Food and Drug Administration (FDA) on Tuesday finalized two guidance documents: one on factors to consider when making benefit-risk determinations for premarket approval (PMA) and de novo classifications, and one on the concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information (PPI) that may inform benefit-risk determinations.

Categories: News, US, CDRH, Government affairs, In vitro diagnostics, Medical Devices, Preclinical, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: FDA guidance, medical device guidance, benefit-risk determinations of devices

FDA Proposes New Rule to Overhaul Regulations for Nonclinical Studies By Zachary Brennan - Published 23 August 2016

The US Food and Drug Administration (FDA) on Tuesday proposed to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach for these safety and toxicity studies.

Categories: News, US, FDA, Clinical, Drugs, Due Diligence, Medical Devices, Preclinical

Tags: GLP regulations, nonclinical studies, quality inspections, FDA proposed rules

Asia Regulatory Roundup: CFDA Revises Preclinical Guidance (23 August 2016) By Nick Paul Taylor - Published 23 August 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Drugs, Due Diligence, Preclinical

Tags: Asia Regulatory Roundup, preclinical guidance, CFDA reforms

EMA Offers First Guidance Devoted Entirely to PBPK Modelling By Zachary Brennan - Published 29 July 2016

The European Medicines Agency (EMA) on Friday unveiled its first-ever draft guideline focused on the use of physiologically-based pharmacokinetic (PBPK) modelling.

Categories: News, Europe, EMA, Preclinical, Regulatory intelligence, Regulatory strategy, Research and development

Tags: PBPK modelling, EMA guidance, MAA dossier