Search Results for Patients

Showing 1 – 25  of 33

UK’s MHRA Cautions Diabetics on Roche’s Leaky Insulin Cartridges By Zachary Brennan - Published 16 August 2016

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that patients with diabetes using Roche’s Accu-Chek Insight insulin pump should be careful when inserting pre-filled insulin cartridges as Roche has reported an increasing number of instances when patients experienced leaking insulin cartridges.

Categories: News, Europe, MHRA, Crisis management, Drugs, Government affairs, Medical Devices, Postmarket surveillance, Quality

Tags: Roche, insulin pumps, leaking insulin pumps, patients with diabetes, MHRA alerts

EMA and FDA Begin Collaborations on Patient Engagement By Zachary Brennan - Published 22 June 2016

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on Wednesday began exchanging more information on the best practices of involving patients in the development, evaluation and post-authorization tracking of medicines.

Categories: News, Europe, US, FDA, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development

Tags: EMA cluster, patient engagement, drug regulators working with patients

FDA Offers New Draft Guidance on How Device Manufacturers Can Share Data With Patients By Zachary Brennan - Published 09 June 2016

As patients increasingly play a more active role in their own healthcare, the US Food and Drug Administration (FDA) on Thursday issued new draft guidance to clarify that medical device manufacturers may share patient-specific information recorded, stored, processed, retrieved and/or derived from a device that helps to treat or diagnose that patient.

Categories: News, US, FDA, Compliance, Labeling, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: medical device guidance, data sharing with patients, FDA guidance

Patient-Focused Drug Development Tracker By Alexander Gaffney, RAC - Published 01 July 2015

The US Food and Drug Administration's patient-focused drug development program is poised to overhaul how drugs are approved for rare and inadequately served diseases and conditions. This tracker provides an in-depth look at what questions FDA is asking of patients and their representatives.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Drugs, Orphan products

Tags: Patients, Patient-Focused Drug Development, FDASIA, View of Patients, PFDD

BIO Calls for Increased Emphasis on Patient Perspectives by Biopharma, FDA By Alexander Gaffney, RAC - Published 17 June 2015

Biopharmaceutical companies should seek out and incorporate the perspective of patients earlier on in the drug development process, a new white paper from the Biotechnology Industry Organization (BIO) argues.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: Patients, Patient Preference, Structured Benefit Risk Framework, Whitepaper, Patient Centered Drug Development

Senators Seek to Expedite FDA Review of 'Breakthrough' Medical Devices By Alexander Gaffney, RAC - Published 27 April 2015

Medical device manufacturers may soon benefit from an expedited review pathway now only afforded to "breakthrough" pharmaceutical products if a bipartisan trio of US legislators have their way.

Categories: News, US, CDRH, Medical Devices

Tags: Breakthrough Therapy, Breakthrough Device, Breakthrough Technology, Advancing Breakthrough Devices for Patients Act, Congress, Senate, Legislation, Bill

Does FDA Need New Authority to Regulate Complex Generic Drugs? By Alexander Gaffney, RAC - Published 01 April 2015

New legislation introduced in the US House of Representatives seeks a government investigation into the US Food and Drug Administration's (FDA) review of complex generic pharmaceuticals to consider whether the agency is in need of new regulatory authority.

Categories: News, US, CDER, Generic drugs

Tags: Bill, Congress, Legislation, Generic Complex Drugs Safety and Effectiveness for Patients Act, Nonbiologic Complex Drugs, Complex Generic Drugs

China New Drug Applications 2004–14: Regulatory Considerations for Clinical Development Supporting Their Approval By Ji Wang, Jun Zuo, Hua Zhang, Thuy Dang and Joseph Scheeren, PharmD - Published 23 April 2015

A review of the clinical development process of 148 new chemical entities (NCEs) and new therapeutic biological products approved in China from 2004 through mid-2014, providing insights into critical regulatory considerations influencing the number of clinical trial patients and choice of development pathway needed to gain regulatory approval in China.

Categories: Features, China, Biologics and biotechnology, Clinical, Drugs, Submission and registration

Tags: China, CFDA, China Food and Drug Administration, clinical trials, new drug approvals, new biologics approvals, Chinese patients, international multicenter trials, IMCT, Asia Pacific

How can FDA be Improved? Patient Groups Offer Ideas By Alexander Gaffney, RAC - Published 10 December 2014

More than a dozen patient groups and trade associations are offering their advice to the US Food and Drug Administration (FDA) on ways the agency can improve its regulatory and administrative processes to take into account the views and expertise of patients and their advocates.

Categories: News, US, FDA

Tags: FDASIA, Patients, Patient Groups, Patient-Centered Drug Development, FDASIA Section 917, Recommendations for FDA

Is FDA Listening Enough to Patients? Agency Wants Feedback By Alexander Gaffney, RAC - Published 03 November 2014

When Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in 2012, its patient-centered provisions were among the biggest changes set to impact the culture of the US Food and Drug Administration (FDA). Now, two years later and with major planning already underway regarding the future of FDA's patient-centered activities, agency regulators are reaching out to the public to ask what more they can do to improve their efforts.

Categories: News, FDA, Drugs, Medical Devices

Tags: Patient-Focused Drug Development, Patients, Patient Groups, Patient Preference Initiative, FDASIA

FDA Seeks Patient Insight Into Autism, Depression and 14 Other Conditions By Alexander Gaffney, RAC - Published 08 October 2014

The US Food and Drug Administration (FDA) has announced a second batch of meetings intended to facilitate the development of drugs for neglected conditions by taking into account the perspective of the patients suffering from the conditions.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: Patient-Focused Drug Development, FDASIA, FDASIA Section X, Patients

Filling a Regulatory Void: Patient Advocates Submit Guidance for Duchenne Muscular Dystrophy By Raymond A. Huml, MS, DVM, RAC - Published 07 August 2014

This article describes the first-ever patient advocacy group draft guidance to FDA on any disease, focusing on Muscular Dystrophy and potential ways to improve chances of development success for new therapies.

Categories: News, US, FDA, Regulatory strategy

Tags: DMD, Muscular Dystrophy, Guidance, Patients, Patient-Developed Guidance, FDA Guidance, Duchenne Muscular Dystrophy

FDA to Focus on Blood, Platelet Disorders at Upcoming Meeting With Patients By Alexander Gaffney, RAC - Published 08 July 2014

US regulators have announced they will soon hold their tenth patient-focused drug development meeting, this time focusing on a collection of blood and platelet disorders that includes hemophilia A, hemophilia B, and von Willebrand disease.

Categories: News, US, CDER, Biologics and biotechnology, Orphan products

Tags: Patient-Focused Drug Development, PFDD, FDASIA, Patients, Blood, Platelet

FDA to Focus on Idiopathic Pulmonary Fibrosis at Upcoming Patient Meeting By Alexander Gaffney, RAC - Published 07 July 2014

FDA is gearing up for its ninth patient-focused drug development meeting, this time focusing on the views of patients with idiopathic pulmonary fibrosis (IPF), a debilitating and often deadly disease which progressively attacks a patient's lungs.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Drugs, Orphan products

Tags: Patient-Focused Drug Development, FDASIA, PFDD, Patients, Patient

New Patient-Focused Drug Development Meeting to Concentrate on Neurologic Disorders By Alexander Gaffney, RAC - Published 24 April 2014

Categories: US, FDA, CDER

Tags: Patient-Centered Drug Development, FDASIA, Latest News, patients

EMA Looks to Formalize Involvement of Patients Within the Regulatory Process By Alexander Gaffney, RF News Editor - Published 29 October 2013

Categories: EMA

Tags: patients, EU

Fourth Patient-Focused Drug Development Meeting Announced With Focus on Common Questions By Alexander Gaffney, RF News Editor - Published 18 July 2013

Categories: US, FDA

Tags: patients

Lung Cancer Focus of Upcoming Patient-Focused Drug Development Meeting By Alexander Gaffney, RF News Editor - Published 21 May 2013

Categories: US, FDA

Tags: patients

Patients First: FDA's New Website Aims to Make Regulations Clear to Everyone, Invite Involvement By Alexander Gaffney, RF News Editor - Published 23 April 2013

Categories: US, FDA

Tags: patients

Overestimated Efficacy, Underestimated Risks Guide Patient Treatment Options By Alexander Gaffney, RF News Editor - Published 13 November 2012

Tags: Physicians, Benefit, Treatment, Latest News, patients, safety, risk

Report: Compassionate Use Exemptions Being Granted in Increasing Numbers Published 24 October 2012

Categories: FDA

Tags: Compassionate Use, IND, Latest News, patients, clinical trials

PCORI: Industry Likely Skewing Trial Outcomes to Detriment of Patients, Regulators By Alexander Gaffney - Published 26 July 2012

Tags: Report, PCORI, Latest News, research, patients, industry, clinical trials

Perspective: Advancing Breakthrough Therapies for Patients By Jennifer Dudinak, PharmD - Published 29 June 2012

This article discusses the Advancing Breakthrough Therapies for Patients Act-- a piece of new draft legislation with the goal of reducing total development time and cost of breakthrough treatments, as well as minimizing the number of patients given a "control" regimen known to have limited benefit.

Categories: Features

Tags: Advancing Breakthrough Therapies for Patients Act, ABTP Act, Breakthrough, Legislation, House, Senate, Orphan

New Provisions in Senate User Fee Bill as Vote Scheduled By Alexander Gaffney - Published 17 May 2012

Tags: Enzi, Harkin, FDASIA, Legislation, User Fee, Latest News, Senate, Bill, patients, data, clinical trials

FDA Plans Meeting to Explore Ways to Involve Patient Advocacy Groups in Regulatory Decision-making By Alexander Gaffney - Published 19 April 2012

Categories: FDA

Tags: Patient Network program, Health Professional Groups, Patient Advocacy Groups, Meeting, Latest News, patients, regulatory