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Filtering on: "topics clinical"

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Transparency: FDA to Release Portions of Redacted Clinical Study Reports By Zachary Brennan - Published 16 January 2018

As part of a push to be more transparent about its decision making, the US Food and Drug Administration (FDA) on Tuesday announced it will launch a pilot project to publicly release portions of clinical trial-related summaries from the pivotal trials that were submitted to the FDA by the drug’s sponsor.

Categories: News, US, FDA, Clinical, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: FDA transparency, Johns Hopkins, Gottlieb

Bioethicists Say Federal Right-to-Try Legislation Will Have Limited Impact on Access By Michael Mezher - Published 11 January 2018

In a perspective published in the New England Journal of Medicine on Wednesday, bioethicists Holly Fernandez Lynch and Steven Joffe of the University of Pennsylvania warn that federal "right-to-try" legislation could undermine the US Food and Drug Administration's (FDA) public health mission and will have a limited impact on improving patient access to investigational products.

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

Tags: Right-to-Try, Expanded Access

EMA Adopts Guideline on Clinical Trials for Rheumatoid Arthritis Treatments By Zachary Brennan - Published 10 January 2018

The European Medicines Agency (EMA) on Wednesday announced the adoption of a guideline, first drafted in 2011, on the clinical evaluation of medicinal products in the treatment of the autoimmune disease rheumatoid arthritis (RA).

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: rheumatoid arthritis, EMA guideline

Trial Transparency: NIH Says Final Rule From 2017 has Helped By Zachary Brennan - Published 09 January 2018

Almost a year ago, the National Institutes of Health (NIH) made effective a new policy to better disseminate information from NIH-funded clinical trials through ClinicalTrials.gov, and the agency says that so far, it’s seen some improvements.

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

Tags: NIH, clinical trial transparency, final rule, FDAAA

Researchers Pilot Ingestible Electronic Sensor to Monitor Microbiome By Zachary Brennan - Published 08 January 2018

Australian researchers have conducted a human trial that they say illustrated the potential role for electronic-based gas-sensing capsules in understanding aspects of the intestine and its microbiota in health, according to an article published online on Monday in Nature Electronics.

Categories: News, Oceania, US, FDA, Clinical, Drugs

Tags: electronic pill, ingestible sensor, Otsuka

Regulatory Strategies for OTC Switch Programs, Implementing EU MDR & IVDR and a Preview of January By Gloria Hall - Published 22 December 2017

Feature articles over the past several weeks provided background, approaches, regulatory considerations, and strategies for implementing prescription to Over-the-Counter (Rx-to-OTC) switch programs; CE marking requirements of IVD medical devices under the new EU regulation; explanation of Annex I general requirements and essential requirements; implementation strategies for the new EU medical devices regulations; and medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes in India.

Categories: Features, India, Europe, US, Clinical, Over the counter drugs, Prescription drugs, In vitro diagnostics, Medical Devices

Tags: Feature Editorial

Regulatory Challenges for Direct-to-Patient Clinical Trials By Andrea Zobel - Published 22 December 2017

On-site clinical trials may present a number of participation obstacles for individuals living at distances from clinical trial sites or for patients with mobility problems. Direct-to-patient clinical trials can be an alternative. This article reviews applicable regulations and analyzes current strategies for conducting direct-to-patient clinical trials using technologies, such as mobile 'apps' and wearables to report data, as well as the potential for sending trial drugs directly to participants. The author recommends ways to improve the regulatory landscape for direct-to-patient clinical trial participation and provides examples of best practices for working with regulatory agencies to ensure the efficacy and success of such trials.

Categories: Features, Europe, US, EC, EMA, FDA, ICH, Clinical, Drugs

Tags: Clinical Trials, Good Clinical Practice, Data Privacy, Direct-to-Patient Trials

Asia Regulatory Roundup: TGA Resists Industry Pressure to Change Adverse Event Reporting Timelines (19 December 2017) By Nick Paul Taylor - Published 19 December 2017

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

Categories: News, Asia, CFDA, TGA, Biologics and biotechnology, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, adverse event, clinical trials China

FDA Closes Loophole Companies Used to Skirt Pediatric Study Requirements By Zachary Brennan - Published 19 December 2017

The US Food and Drug Administration (FDA) on Tuesday released draft guidance indicating that it no longer intends to grant orphan drug designation to drugs for pediatric subpopulations of common diseases except for under certain conditions.

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

Tags: pediatric research, orphan designation, pediatric subpopulation

Updated: House and Senate Pass Tax Overhaul By Zachary Brennan - Published 20 December 2017

The US House of Representatives on Tuesday afternoon voted 227 to 203 in favor of passing the GOP's tax overhaul bill, with no Democrats voting for the bill and 12 Republicans voting against it. The Senate early Wednesday morning also passed the bill and then the House passed the bill again in a redo vote after several provisions had to be pulled for violations of the Byrd Rule.

Categories: News, US, Clinical, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: tax bill, Senate vote, House vote

Senate, House Agree to Cut Orphan Drug Research Credit in Half in Tax Bill By Zachary Brennan - Published 18 December 2017

Members of the House-Senate Conference Committee discussing the GOP's tax overhaul plan on Friday released the final text of the bill, which would reduce the rare disease research tax credits biopharma companies can claim by half.

Categories: News, US, Clinical, Orphan products, Research and development

Tags: orphan drug research, research tax credit, tax bill

Nanomaterials: FDA Issues Draft Guidance for Drugs and Biologics By Michael Mezher - Published 18 December 2017

The US Food and Drug Administration (FDA) on Friday issued draft guidance detailing a risk-based framework for drugs and biologics containing nanomaterials or made using nanotechnology.

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

Tags: Nanomaterials, Nanotechnology, Draft Guidance

FDA Offers Two New Draft Guidances on Developing Targeted Therapies By Zachary Brennan - Published 15 December 2017

The US Food and Drug Administration (FDA) on Friday published two new draft guidance documents that seek to support the development of treatments that address the underlying genetic mutations that often cause or contribute to diseases and another discussing how to determine if an in vitro diagnostic (IVD) device used in a study must undergo its own FDA review, distinct from the drug study.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs, In vitro diagnostics, Regulatory intelligence, Regulatory strategy

Tags: tumor agnostic approvals, investigational IVDs, genetic mutation

FDA Discusses Device Least Burdensome Provisions in New Draft Guidance By Michael Mezher - Published 14 December 2017

After signaling that it would shift more of the regulatory oversight of medical devices to the postmarket setting, the US Food and Drug Administration (FDA) on Thursday issued a new draft guidance detailing updates to its least burdensome approach to regulating devices.

Categories: News, US, CDRH, Clinical, Medical Devices, Postmarket surveillance, Preclinical, Submission and registration

Tags: Least Burdensome, FDASIA, 21st Century Cures, Alternative 510(k) Pathway

CDRH Sees Spike in Pre-Market Submissions With Patient-Reported Outcome Measures By Zachary Brennan - Published 12 December 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday issued its first report on patient-reported outcomes (PROs), noting a significant uptick in PRO data submitted in 2017.

Categories: News, CDRH, Clinical, In vitro diagnostics, Medical Devices, Postmarket surveillance

Tags: patient-reported outcomes, medical device submissions

French Regulators Set Up Dedicated Unit for Overseeing Early Stage Clinical Trials By Michael Mezher - Published 11 December 2017

France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week announced that it is setting up a new unit dedicated to overseeing first-in-human and other early stage clinical trials.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs

Tags: First-in-Human, Clinical Trials, ANSM, Bial

More Efficient Rare Pediatric Drug Development: FDA Drafts Guidance By Zachary Brennan - Published 06 December 2017

The US Food and Drug Administration (FDA) on Wednesday released draft guidance that could speed the development of treatments for rare pediatric disease drugs.

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

Tags: rare pediatric disease, Gaucher, FDA draft guidance

Sanofi and J&J Lead the Way With Clinical Trial Transparency, Study Finds By Zachary Brennan - Published 05 December 2017

Clinical trial transparency among large pharmaceutical companies is high, although opportunities for improvement remain, according to a study published Tuesday in the BMJ.

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

Tags: clinical trial transparency, Johnson & Johnson, Sanofi, Valeant, Allergan

NEST Seeks Medical Device Test Cases for Using Real World Evidence By Zachary Brennan - Published 05 December 2017

The National Evaluation System for health Technology Coordinating Center (NESTcc) this week put out three requests for proposals to help it build the case for using real world evidence for regulatory and coverage decisions for medical devices.

Categories: News, US, FDA, Clinical, In vitro diagnostics, Medical Devices, Postmarket surveillance, Preclinical, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: NEST, NESTcc, real world data, real world evidence

CE Marking of In Vitro Diagnostic Medical Devices Under the New EU Regulation By Jonathan Bray, PhD, Michelle O'Connor, PhD, Robert D. Cumming - Published 01 December 2017

This article explains the revised classification rules, conformity assessment procedures and new requirements for clinical evidence to support the safety and performance of an In Vitro Diagnostic (IVD) medical device. Of significance, the In Vitro Diagnostic Device Regulations (EU 2017/746) transition from the prior two class system under the IVD Directive (98/19/EC) to a four-class, risk-based classification system.1 The regulations, intended to affect greater IVD safety and reliability, expand the definition of an IVD to include software used as any part of an IVD, as well as an IVD used for providing information concerning the predisposition to a medical condition or disease. An IVD also may be a device used to predict a treatment response or reaction to a treatment. Moving forward, all Class B through Class D IVDs will require some level of conformity assessment by an independent Notified Body.

Categories: Features, Europe, EC, Clinical, In vitro diagnostics, Medical Devices, Submission and registration

Tags: MDR, IVDR, CE Marking

FDA, EMA and PMDA Plot Harmonized Path for Antibiotics By Michael Mezher - Published 17 November 2017

Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), met in Tokyo last month to plot out an approach that would allow drugmakers to conduct a single development plan for new antibiotics.

Categories: News, EMA, FDA, PMDA, Clinical, Drugs, Preclinical

Tags: Antimicrobial Resistance, AMR, Antibiotics, Harmonization

Updated: House Passes GOP Tax Overhaul With Orphan Drug Tax Credit Repeal Included By Zachary Brennan - Published 16 November 2017

The US House of Representatives on Thursday passed a bill to reform the US tax code by a vote of 227 to 205, with all Democrats voting against it and all but 13 Republicans voting for it.

Categories: News, US, FDA, Clinical, Reimbursement, Research and development

Tags: orphan drug tax credit, tax reform

Experts Tell Senate Committee Current Gene Editing Regulations are Appropriate By Michael Mezher - Published 14 November 2017

At a Senate Health, Education, Labor and Pensions (HELP) hearing in Washington, D.C. on Tuesday, experts explained that the current regulatory framework for gene editing in the US is appropriate and cautioned that an overly strict approach could drive research to other countries.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Ethics

Tags: Gene Editing, Gene Therapy, CRISPR, CRISPR-Cas9, Editas

Why Don't EMA and FDA Speak With the Same Voice on Flu Treatments? Researchers Investigate By Zachary Brennan - Published 13 November 2017

New research published last week digs into cross-national regulatory divergences, with a focus on why some US labels for certain flu treatments say the medicines have not been proven to reduce complications while EU labels claim the opposite.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Government affairs

Tags: Relenza, Tamiflu, regulatory divergence

Senate Tax Plan Seeks to Reform, Rather Than Repeal, Orphan Drug Tax Credit By Zachary Brennan - Published 10 November 2017

The Senate’s tax plan, running counter to the House’s call to eliminate the orphan drug tax credit for research on drugs to treat rare diseases, seeks to modify the credit instead.

Categories: News, US, Clinical, Research and development

Tags: GOP tax plan, Senate tax reform, Hatch, orphan drug tax credit