Search Results for drug development

Showing 1 – 25  of 44

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's Woodcock: The Clinical Trials System is 'Broken' By Zachary Brennan - Published 20 September 2017

The clinical trials system is "broken" and there needs to be new ways to collect and utilize patient data, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told a workshop on real world evidence (RWE) at the National Academies of Sciences, Engineering, and Medicine on Wednesday.

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

Tags: Janet Woodcock, real world evidence, real world data, drug development

FDA Finalizes Guidance on Antibacterial Therapies for Unmet Needs By Zachary Brennan - Published 01 August 2017

The US Food and Drug Administration (FDA) on Tuesday finalized guidance first drafted in 2013 to assist sponsors in the development of new antibacterial drugs for the treatment of serious bacterial diseases in patients with an unmet medical need.

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

Tags: antibacterials, LPAD, streamlined drug development

FDA Offers Biomarker Qualification Case Studies By Zachary Brennan - Published 14 June 2017

As part of an educational series on qualifying biomarkers for use in drug development, the US Food and Drug Administration (FDA) has released two fictitious examples of how biomarkers can improve the drug development process and how FDA works with researchers, pharmaceutical companies and patient advocates to qualify biomarkers.

Categories: News, US, CDER, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: biomarker qualification, FDA case studies, biomarkers, drug development

Qualification of Drug Development Tools: FDA Updates Process By Zachary Brennan - Published 08 June 2017

Thanks to the 21st Century Cures Act, there will be an updated, multi-stage process for qualifying Drug Development Tools (DDTs), which can include biomarkers, animal models and clinical outcome assessments.

Categories: News, US, CDER, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: DDT, drug development tools, biomarkers, clinical outcome assessments

EMA Consults on Regulatory Requirements for Chronic Liver Disease Drugs By Michael Mezher - Published 01 June 2017

The European Medicines Agency (EMA) on Thursday launched a public consultation to gather input on a future reflection paper discussing the regulatory requirements for developing drugs to treat chronic non-infectious liver diseases.

Categories: News, Europe, EMA, Clinical, Drugs, Research and development, Submission and registration

Tags: NASH, PCS, PBC, Liver Disease, Drug Development

FDA Begins Consultation on Update to ICH Pediatric Clinical Trials Guidance By Michael Mezher - Published 21 November 2016

The US Food and Drug Administration (FDA) on Monday launched a three-month public consultation on an addendum to the International Council for Harmonisation's (ICH) guidance on pediatric clinical trials.

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

Tags: Pediatric drug development, ICH E11

PDUFA VI: Highlights on What to Expect By Zachary Brennan - Published 15 August 2016

The US Food and Drug Administration (FDA) and stakeholders from industry and patient groups on Monday outlined the agreement they forged on the next reauthorization of the Prescription Drug User Fee Act (PDUFA) that begins in 2017, focusing on what’s to come on pre-market reviews, postmarket safety, regulatory decision tools and other ways FDA is preparing for the future of drug development.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: PDUFA, PDUFA VI, real-world evidence, Sentinel, model-informed drug development

EMA Revises Guidance on Developing New TB Medicines By Zachary Brennan - Published 01 August 2016

The European Medicines Agency (EMA) on Monday launched a public consultation on revised guidance for companies developing new drugs to treat tuberculosis (TB).

Categories: News, Europe, EMA, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: TB drugs, tuberculosis, drug development guidance EU

FDA Offers New Draft Guidance on Bioequivalence Studies for 19 Generics, 19 Revisions By Zachary Brennan - Published 16 June 2016

The US Food and Drug Administration (FDA) on Thursday released 38 new and revised draft guidance documents for drugmakers looking to begin research and development for new generics, including for some blockbuster drugs that have not yet lost patent protection.

Categories: News, US, FDA, Compliance, Generic drugs, Due Diligence, Government affairs, Research and development

Tags: Viekra Pak, Eli Lilly, AstraZeneca, generic drug draft guidance, generic drug development

EMA Offers New Draft Guidance on Developing Alzheimer’s Treatments By Zachary Brennan - Published 01 February 2016

The European Medicines Agency (EMA) on Monday released new draft guidance on the development of Alzheimer’s disease treatments that would allow treatments to be evaluated in earlier disease stages before dementia sets in.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Preclinical, Project management, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: Alzheimer's disease, dementia treatment, guidance on dementia, Alzheimer's drug development

CDER’s Woodcock Outlines Priorities for 2016 By Zachary Brennan - Published 14 December 2015

With a banner year for new drug approvals under its belt in 2015 (42 approvals and counting), the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is now looking at how it can negotiate three new user fee agreements and fill an enormous number of staff vacancies this year.

Categories: News, US, CDER, Active pharmaceutical ingredients, Biologics and biotechnology, Combination products, Drugs, Due Diligence, Government affairs, Manufacturing, Postmarket surveillance, Quality, Research and development

Tags: CDER, Janet Woodcock, FDA, drug development 2016, drug approvals

FDA Finalizes HIV Drug Development Guidance By Michael Mezher - Published 02 November 2015

The US Food and Drug Administration (FDA) has added more detailed definitions for treatment-naïve and treatment-experienced HIV patients and provides recommendations for designing switch trials, according to guidance finalized Monday.

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

Tags: HIV, HIV-1, Drug development programs, Switch trials

Senators Propose New Exclusivity Voucher, Priority Review Voucher Programs By Zachary Brennan - Published 22 October 2015

Senators on both sides of the aisle are trying to incentivize the development of new drugs for newborn babies and medical countermeasures via a new exclusivity voucher and a priority review voucher system that are similar to the voucher programs already linked to tropical and rare pediatric disease treatments.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement, Submission and registration

Tags: priority review voucher programs, PRV, pediatric disease, neonatal drug development, medical countermeasures, Senator Bob Casey

EMA Sees Increase in Early Dialogue with Biosimilar, New Drug Developers By Zachary Brennan - Published 06 October 2015

The European Medicines Agency (EMA) is seeing a sharp rise in demand from drug developers seeking dialogue earlier in the drug development process, particularly for biosimilars and drugs with a new active substance, EMA's management board said Tuesday in an update on the first half of 2015.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: EMA, industry interactions, biosimilars, drug development

Bipartisan Group of Senators Introduces Bill to Speed Development of Rare Disease Drugs By Zachary Brennan - Published 16 September 2015

A new bipartisan bill aims to help accelerate the development of targeted drugs to treat rare diseases, including Duchenne muscular dystrophy, cystic fibrosis, some cancers and other genetic diseases.

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

Tags: rare disease drug development, orphan drugs, OOPD, FDA, bipartisan legislation

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

FDA to Focus on Autism, Psoriasis Under New Patient-Focused Program By Alexander Gaffney, RAC - Published 01 July 2015

The US Food and Drug Administration (FDA) has released a pared-down list of diseases it plans to assess over the coming two years as part of its Patient-Focused Drug Development (PFDD) program—an integral part of the most recent authorization of the Prescription Drug User Fee Act (PDUFA).

Categories: News, US, CDER

Tags: PFDD, Patient-Focused Drug Development

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

Can Drug Development be Accelerated? FDA Wants Help By Alexander Gaffney, RAC - Published 12 February 2015

The US Food and Drug Administration (FDA) is soliciting input on how it might accelerate the development of certain drug products through the use of new and emerging biomarkers.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Drugs, In vitro diagnostics, Preclinical

Tags: Biomarkers, Drug Development Tools, DDTs, Drug Development Qualification Program

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

Breaking Bottlenecks: FDA Clarifies Tool for Expediting Drug Development (Corrected) By Alexander Gaffney, RAC - Published 07 October 2014

The US Food and Drug Administration (FDA) is trying to clarify how industry can request a meeting of the agency's Critical Path Institute (C-Path), a decade-old effort to accelerate drug development through the use of common standards.

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

Tags: Guidance, Draft Guidance, C-Path, Critical Path Initiative, Critical Path Institute, Critical Path Innovation Meetings, CPIM, DDTs, Drug Development Tools, Biomarker Qualification

FDA Wants Input on Patient-Developed DMD Guidance By Alexander Gaffney, RAC - Published 03 September 2014

The US Food and Drug Administration (FDA) is calling for public comment on a new draft guidance document developed by patient advocates and intended to accelerate the development of therapies to treat Duchenne Muscular Dystrophy (DMD).

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

Tags: DMD, Draft Guidance, PPMD, DMD Guidance, Patient-Centered Drug Development