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EMA Offers Draft Guideline on Serious Breaches of Clinical Trial Regulations By Zachary Brennan - Published 23 May 2017

The European Medicines Agency (EMA) on Tuesday opened for public consultation a new guideline on serious breaches of clinical trial regulations or clinical trial protocols.

Categories: News, Europe, EMA, Clinical, Compliance, Government affairs, Research and development

Tags: clinical trial regulations, EMA guideline

Petition to FDA Seeks to Modify Trial Regulations Following Deaths By Zachary Brennan - Published 18 May 2017

A petition submitted to the US Food and Drug Administration (FDA) in 2016 has been updated recently, as it seeks to reform FDA requirements for investigational new drug (IND) applications, investigational device exemptions (IDEs) and new drug applications (NDAs).

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

Tags: citizen petition, FDA petition, clinical trial regulations

FDA Adds Boxed Warning to Janssen's Type 2 Diabetes Drug Label By Zachary Brennan - Published 16 May 2017

Based on new data from two large clinical trials, the US Food and Drug Administration (FDA) on Tuesday concluded that Janssen’s type 2 diabetes medicine canagliflozin (brand names include Invokana, Invokamet and Invokamet XR) causes an increased risk of leg and foot amputations.

Categories: News, Europe, US, EMA, FDA, MHRA, Clinical, Crisis management, Drugs, Postmarket surveillance

Tags: Janssen, SGLT2 inhibitors, FDA warning

FDA Issues New and Revised Guidance for Generic Drugs By Michael Mezher - Published 16 May 2017

The US Food and Drug Administration (FDA) on Tuesday released a batch of 21 new and 16 revised draft guidances intended to help drugmakers conduct the studies needed to support the approval of certain generic drugs.

Categories: News, US, FDA, Clinical, Generic drugs, Submission and registration

Tags: Product-Specific Guidance, Bioequivalence

EMA Report on 2016: 27 New Drugs, New Priority Scheme, Trial Transparency By Zachary Brennan - Published 10 May 2017

With the European Medicines Agency’s (EMA) departure from London and loss of UK expertise (about 60 of the 897 EMA staffers are from the UK) looking more likely, the agency on Wednesday released a report outlining its successes from 2016, when 27 new medicines were authorized and several new programs took shape.

Categories: News, Europe, EC, EMA, Active pharmaceutical ingredients, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: PRIME, Brexit, EMA in 2016

FDA Drug Approvals on Limited Evidence: Follow-Ups Lacking, Study Finds By Zachary Brennan - Published 08 May 2017

For drugs approved by the US Food and Drug Administration (FDA) based on limited evidence, a recent study published in the British Medical Journal found “noticeable variability” in the degree to which novel drugs were studied in the postmarket period.

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

Tags: surrogate markers, clinical endpoints, postapproval studies

House and Senate Revive Bill Targeting Generic Drug Delays By Zachary Brennan - Published 27 April 2017

Leaders of the Senate and House Judiciary Committees, led by Sen. Patrick Leahy (D-VT), on Thursday re-introduced legislation to combat anticompetitive practices that can block the market entry of lower-cost generic drugs. 

Categories: News, US, FDA, Clinical, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: CREATES Act, generic drug delay, REMS, Leahy

Impact of the Revised EU Clinical Trial Regulation By Siegfried Schmitt, Federico Bonacci, MD, Daniela Lisini, PhD, Dr. Viviana Mascilongo - Published 24 April 2017

Clinical Trial Regulation EU No 536/2014 will come into effect in 2018. This article reports on aspects of the revised regulation and evaluates its potential impact on clinical trials conducted to assess medicinal products for human use. It discusses changes impacting the critical role of the Ethics Committees in the approval process for clinical trials as well as the planned, centralized data reporting channel, referred to as "the portal." While revisions to the regulation are still underway, readers will benefit from the assessment of its current status and anticipated developments.

Categories: Features, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs

Tags: Clinical Trial Regulation, EU No 536/2014

FDA Warns LA-Based Medical Food Company for Clinical Trial Without an IND By Zachary Brennan - Published 18 April 2017

The US Food and Drug Administration (FDA) warning letter released Tuesday says that Los Angeles-based Targeted Medical Pharma ran a clinical investigation of a medical food without first submitting an investigational new drug (IND) application to the agency.

Categories: News, US, FDA, Clinical, Compliance, Crisis management, Nutritional and dietary supplements, Research and development

Tags: warning letter, LA medical foods, medical food clinical trial

EMA Updates Guidance on Clinical Data Publication Policy By Michael Mezher - Published 14 April 2017

The European Medicines Agency (EMA) on Wednesday released a revised version of its guidance on complying with its new policy on the publication of clinical data that went into effect last fall.

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

EMA Offers Draft Guideline on Trial Master Files By Zachary Brennan - Published 13 April 2017

The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline to assist sponsors and investigators looking to comply with the requirements of the clinical trial master file (TMF), which includes documentation to allow monitoring by the sponsor and member state inspections.

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

Tags: trial master file, EMA guideline

FDA Approves First DTC Tests Evaluating Genetic Risk Information By Zachary Brennan - Published 06 April 2017

The US Food and Drug Administration (FDA) on Thursday authorized the first direct-to-consumer genetic health risk tests for 10 diseases and conditions.

Categories: News, US, CDRH, Clinical, In vitro diagnostics, Medical Devices

Tags: 23andMe, direct to consumer genetic tests, genetic tests, Alzheimer's, Parkinson's

FDA Offers its Views on Medical Device Trials By Zachary Brennan - Published 06 April 2017

Officials from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) took to the New England Journal of Medicine on Thursday to explain the wide array of clinical trial designs and data sources that may be used to support the safety and effectiveness of medical devices.

Categories: News, US, CDRH, Clinical, Medical Devices

Tags: CDRH, medical device trials, FDA views

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

FDA Warns Pfizer Clinical Investigator Over Chantix Study By Zachary Brennan - Published 05 April 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent in January to a clinical investigator working on a study of Pfizer’s nicotine addiction treatment Chantix (varenicline tartrate).

Categories: News, US, FDA, Clinical, Compliance, Drugs, Due Diligence

Tags: Chantix, Pfizer, clinical trial, warning letter

EMA Adopts Updated Guideline on Fixed Dose Combination Drugs By Michael Mezher - Published 03 April 2017

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) last week adopted an updated guideline on clinical development for fixed combination drugs, which is expected to take effect in October.

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

MHRA to No Longer Require Payment in Advance for License Applications By Michael Mezher - Published 31 March 2017

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Friday announced changes to how it handles payments for license applications for drugs and clinical trials.

Categories: News, Europe, MHRA, Clinical, Drugs, Submission and registration

Tags: Fees, Payment

Establishing a Joint Venture Pharmaceutical Manufacturing Entity in Japan By Satoshi Koike, PhD, DSc - Published 23 March 2017

This article focuses on key regulatory activities to establish a Joint Venture (JV) for pharmaceutical manufacturing and sales in Japan. The author describes foundation building, marketing authorization holder responsibilities, new drug applications, clinical trial sponsorship, adverse events reporting and brand name registrations as well as requirements for data archiving and post-marketing regulatory activities.

Categories: Features, Japan, MHLW, PMDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance, Submission and registration

Tags: Common Technical Document, CTD

MHRA Details Common Issues in Clinical Trial Applications By Michael Mezher - Published 23 March 2017

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday issued guidance detailing the most common issues it sees in clinical trial applications in an effort to help sponsors avoid unnecessary delays.

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

Tags: Clinical Trial Applications, Validation

FDA Issues Guidance on Drugs to Prevent Delayed Graft Function in Kidney Transplant Patients By Michael Mezher - Published 23 March 2017

The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance detailing its expectations for drugs intended to treat delayed graft function (DGF) in kidney transplant patients.

Categories: News, US, FDA, Clinical, Drugs, Regulatory strategy

Tags: Delayed Graft Function, DGF, Draft Guidance

Fast Facts: Serious Adverse Event Reporting Requirements in the US By Valerie Fauvelle, MS, RAC - Published 22 March 2017

This article presents reporting requirements for Serious Adverse Events (SAEs) and focuses on an important, but often overlooked regulation that specifies when a study is being run and includes the use of an approved drug. There are reporting requirements with specific timeframes that must be followed if there is a reportable SAE attributed to the approved drug.

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

Tags: Adverse Event Reporting

EMA Seeks Experts on Clinical Data Anonymization By Michael Mezher - Published 22 March 2017

The European Medicines Agency (EMA) on Wednesday issued a call for experts to join a new technical advisory group for anonymizing clinical data.

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

Tags: Clinical Study Reports, Publication, Transparency, Anonymization

FDA Approved Nearly All Expanded Access Requests in FY2016 By Michael Mezher - Published 20 March 2017

The US Food and Drug Administration (FDA) granted more than 99% of requests for patients to access unapproved drugs and biologics in fiscal year 2016, according to data released last week.

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

Tags: Expanded Access, Compassionate Use, Right-To-Try

Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance By Zachary Brennan - Published 16 March 2017

Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday.

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

Tags: GlaxoSmithKline, Regeneron, Novartis, Teva, BIO, Celgene, AstraZeneca, clinical trial endpoints

European Regulatory Roundup: EMA’s PRAC Seeks to Suspend Four Imaging Agents (16 March 2017) By Nick Paul Taylor - Published 16 March 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, Clinical, Drugs, Government affairs

Tags: PRAC, imaging agents, data protection, neutropenic enterocolitis