Search Results for clinical trials

Showing 1 – 25  of 255

Video: FDA Commissioner Scott Gottlieb's Keynote Speech at the 2017 Regulatory Convergence By Zachary Brousseau - Published 28 September 2017

Watch FDA Commissioner Scott Gottlieb's keynote address to attendees of RAPS’ 2017 Regulatory Convergence, focusing on making the clinical end of drug development more efficient and effective.

Tags: FDA, Commissioner, Scott Gottlieb, Regulatory Convergence, drug development, clinical trials, adaptive clinical trials, seamless clinical trials

FDA to Close Loophole Allowing Companies to Skirt Pediatric Study Requirements By Zachary Brennan - Published 12 September 2017

FDA commissioner Scott Gottlieb announced Tuesday that the agency will release guidance to close a loophole that allows companies to avoid their obligation to study pharmaceuticals in pediatric populations.

Categories: News, US, FDA, Clinical, Drugs

Tags: FDARA, PREA, pediatric clinical trials

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

Novel Trial Endpoints Generated by Mobile Tech: CTTI Offers Recommendations By Zachary Brennan - Published 26 June 2017

The Clinical Trials Transformation Initiative (CTTI), a public-private partnership established by Duke University and the US Food and Drug Administration (FDA), on Monday released new recommendations on developing novel clinical trial endpoints generated by mobile technology.

Categories: News, US, FDA, Clinical, Drugs, Medical Devices

Tags: CTTI, mobile technology and clinical trials, novel trial endpoints

Asia Regulatory Roundup: India Sets Guidelines for Fixed-Dose Combination Trials (13 June 2017) By Nick Paul Taylor - Published 13 June 2017

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

Categories: News, Asia, CDSCO, CFDA, Crisis management, Drugs, Government affairs

Tags: Asia Regulatory Roundup, India clinical trials, CFDA guidance

European Regulatory Roundup: EMA Drafts Guidelines on Controlling False Positives in Clinical Trials (6 April 2017) By Nick Paul Taylor - Published 06 April 2017

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

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs, Government affairs

Tags: EU clinical trials, trial endpoints, EMA guideline

Pediatric Cancers: New Bill Seeks to Close Clinical Trial Requirement Loopholes By Zachary Brennan - Published 08 March 2017

A new bipartisan bill reintroduced in the House and Senate in late February, which could ultimately be attached to the reauthorized Prescription Drug User Fee Act (PDUFA), seeks to close the loopholes biopharmaceutical companies use to skirt around clinical trial requirements for cancer treatments in pediatric populations.

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

Tags: pediatric cancer clinical trials, BPCA, PREA, pediatric clinical trials

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

China Works to Reduce Massive Backlog of Clinical Trial and Marketing Applications By Zachary Brennan - Published 15 February 2017

China Food and Drug Administration (CFDA) is facing increasing pressure as a backlog of pharmaceutical marketing and clinical trial applications grow, though trial standards there are approaching those of international standards, according to a perspective published in Nature Reviews Clinical Oncology on Tuesday.

Categories: News, China, CFDA, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs

Tags: CFDA, clinical trials in China, drug approvals in China

ANSM Says Pilot for New Clinical Trials Regulation Enforcement a Success By Michael Mezher - Published 26 January 2017

France's Agency Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) on Wednesday reported positive results for its year-long pilot for assessing clinical trials using the process established in the new EU Clinical Trials Regulation.

Categories: News, Europe, Clinical

Tags: ANSM, Clinical Trials Regulation

Multiple Endpoints in Clinical Trials: FDA Issues Draft Guidance By Zachary Brennan - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday released draft guidance for industry on the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in drug and biologic clinical trials.

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

Tags: endpoints, clinical trials, clinical guidance, FDA guidance

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

When can Non-Inferiority Trials Establish Efficacy? FDA Explains With Guidance By Zachary Brennan - Published 07 November 2016

The US Food and Drug Administration (FDA) on Monday finalized guidance for pharmaceutical and biotech sponsors looking for more advice on when non-inferiority studies demonstrating effectiveness of an investigational drug can provide interpretable results, how to choose the non-inferiority margin and how to test the non-inferiority hypothesis.

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

Tags: non-inferiority trials, clinical trials, trials establishing efficacy, placebo-controlled trials

FDA Report Offers Complicated Picture of Industry Compliance With Postmarket Requirements By Zachary Brennan - Published 28 October 2016

The majority of ongoing postmarketing requirements (PMRs) and postmarketing commitments (PMCs) from Fiscal Years 2013 and 2014 were on schedule, but a large number of companies are still struggling to meet some of these regulatory requirements on time, the US Food and Drug Administration (FDA) said in a new report issued Friday.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance

Tags: postmarketing requirements, postmarketing commitments, PMR, PMC, clinical trials after marketing

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

FDA Offers New Guidance on Qualified Biomarker for COPD Trials By Zachary Brennan - Published 14 September 2016

The US Food and Drug Administration (FDA) on Wednesday issued guidance providing details on the qualified context of use (COU) for the biomarker plasma fibrinogen in interventional clinical trials of patients with chronic obstructive pulmonary disease (COPD) at high risk for exacerbations and/or all-cause mortality.

Categories: News, FDA, Clinical, Drugs

Tags: COPD clinical trials, qualified biomarkers

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: Toxicity Seen in Fatal French Study Does Not Extend to Other FAAH Inhibitors By Zachary Brennan - Published 12 August 2016

The U.S. Food and Drug Administration (FDA) on Friday said that after reviewing the safety information of a first-in-human clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January, the agency found that the toxicity exhibited in the trial does not extend to other drugs in the class, known as fatty acid amide hydrolase (FAAH) inhibitors.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Government affairs, Product withdrawl and retirement, Regulatory intelligence

Tags: Bial, Biotrial, France Phase 1 study, clinical trials, FAAH inhibitors

India Looks to Further Ease Process of Running Clinical Trials By Zachary Brennan - Published 02 August 2016

India’s Central Drugs Standards Control Organization (CDSCO) on Tuesday looked to relax two clinical trial requirements that could make it easier to run trials there.

Categories: News, India, CDSCO, Clinical, Research and development

Tags: clinical trials in India, clinical investigators

FDA Finalizes Guidance on Adaptive Designs for Device Studies By Zachary Brennan - Published 26 July 2016

The US Food and Drug Administration (FDA) on Tuesday finalized guidance that lays out how to design medical device clinical trials that allow for changes based on data, while maintaining study validity and integrity.

Categories: News, US, FDA, Due Diligence, Medical Devices, Research and development

Tags: adaptive trial designs, device clinical trials, final FDA guidance

EMA to Revise Phase I Trial Guidance, Draft Expected in Late 2016 By Michael Mezher - Published 22 July 2016

The European Medicines Agency (EMA) on Thursday announced plans to update its guidelines on first-in-human (FIH) clinical trials following a trial incident in France last January that left one patient dead and five others hospitalized.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Clinical, Preclinical

Tags: First-in-Human, Phase I, Clinical Trials

Device Clinical Studies: FDA Outlines How to Evaluate and Report Age, Race and Ethnic Group Data By Zachary Brennan - Published 17 June 2016

The US Food and Drug Administration (FDA) on Friday released new draft guidance intended to help improve the quality, consistency and transparency of clinical data on the performance of devices for particular patients in various age, race and ethnic groups.

Categories: News, US, CDRH, Clinical, Labeling, Medical Devices, Postmarket surveillance, Preclinical

Tags: medical device clinical trials, device trial populations, clinical trial enrollment

FDA Looks to Revitalize Compassionate Use Program With Simplified Form, Final Guidance By Zachary Brennan - Published 02 June 2016

The US Food and Drug Administration (FDA) on Thursday finalized two question and answer guidance documents on charging for investigational drugs and expanded access for the compassionate use of investigational drugs for those with life-threatening diseases or conditions, as well as a new streamlined form for applying for expanded access.

Categories: News, US, FDA, Clinical, Compliance, Crisis management, Drugs, Regulatory intelligence, Regulatory strategy

Tags: compassionate use, expanded access, access to investigational drug, access to drug in clinical trials

European Commission Unveils Four New Public Consultations on Clinical Trials By Zachary Brennan - Published 02 June 2016

The four new consultations, released Thursday from the European Commission, deal with ethical considerations for pharmaceutical trials with minors, risk proportionate approaches in trials, summaries of trial results for non-specialists or “laypersons,” and definitions of investigational medical products (IMPs) and use of auxiliary medicinal products (AMPs).

Categories: News, Europe, EC, EMA, Clinical, Drugs, Government affairs, Quality, Research and development

Tags: European Commission consultation, clinical trials in EU, pediatric clinical trials

EHR Data in Clinical Trials: New FDA Draft Guidance By Zachary Brennan - Published 16 May 2016

The US Food and Drug Administration (FDA) on Monday released draft guidance to assist clinical trial sponsors, investigators, contract research organizations (CROs), institutional review boards (IRBs) and other using electronic health record (EHR) data in FDA-regulated clinical investigations.

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

Tags: EHR data, EHR guidance, clinical trials and electronic health records, health IT, ONC