Search Results for

Filtering on: "topics clinical"

Showing 1 – 25  of 538

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

Nearly Half of Recent EU Approvals Based on a Single Pivotal Study By Michael Mezher - Published 10 November 2017

A recent study found that 45% of marketing authorizations granted in the EU from 2012 to 2016 were based on evidence from a single pivotal trial.

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

Tags: Pivotal Trials, Single Pivotal Study

Reproductive Toxicity: FDA Consults on Revised ICH Guideline By Michael Mezher - Published 09 November 2017

The US Food and Drug Administration (FDA) on Thursday released a draft guidance for consultation on a revision to the International Council for Harmonization (ICH) guideline on reproductive toxicity testing.

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

Tags: Reproductive Toxicity, ICH, S5(R3), Draft Guideline

EMA Offers Support for More Research on DIVI Biomarkers By Zachary Brennan - Published 09 November 2017

European Medicines Agency (EMA) Executive Director Guido Rasi this week sent a letter of support to the Safer and Faster Evidence-Based Translation (SAFE-T) Consortium and the Predictive Safety Testing Consortium (PSTC) to encourage further study of ways to monitor for drug-induced vascular injury (DIVI) in early clinical drug development.

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

Tags: Guido Rasi, DIVI biomarkers

Drugged Driving: FDA Finalizes Study Guidance By Michael Mezher - Published 08 November 2017

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on how drugmakers should study the effects of their drugs on driving ability.

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

Tags: Driving, Driving Studies, Final Guidance

FDA Finalizes Guidance on Antiviral Drugs for Cold Sores By Michael Mezher - Published 07 November 2017

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on developing antiviral drugs for recurrent herpes labialis (RHL), commonly referred to as cold sores, which affects between 20% and 40% of adults in the US.

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

Tags: Antiviral, Recurrent Herpes Labialis, RHL, Cold Sores

GOP Tax Reform Bill Would Repeal Orphan Drug Research Credits By Zachary Brennan - Published 02 November 2017

Republicans on Thursday rolled out their new tax reform bill, which among other provisions to lower taxes for Americans and businesses, proposes to repeal a provision that might cause the biopharma industry some concern.

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

Tags: orphan drug tax credit, orphan drug research, BIO, Allergan

FDA Opens for Comment Revised ICH Guideline on Statistical Principles for Clinical Trials By Zachary Brennan - Published 30 October 2017

The US Food and Drug Administration (FDA) on Monday opened for comment a newly revised International Council for Harmonisation (ICH) guideline intended to better align the choice of statistical methods with questions of regulatory importance, and to improve the reliability of decisions about and representations of the effects of medical products.

Categories: News, US, FDA, ICH, Clinical, Drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: statistical principles for clinical trials, E9(R1), ICH guidelines

EMA Consults on Revised Factor VIII Product Guidelines By Michael Mezher - Published 30 October 2017

The European Medicines Agency (EMA) on Monday issued two draft revised guidelines on plasma-derived and recombinant coagulation factor VIII products that remove requirements for conducting clinical studies in previously untreated patients (PUPs).

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

Tags: Hemophilia, Factor VIII, Draft Guideline

FDA Issues Disease-Specific Draft Guidance for Pediatric GERD By Michael Mezher - Published 26 October 2017

The US Food and Drug Administration (FDA) on Thursday issued draft guidance detailing clinical considerations for drugmakers looking to develop products to treat pediatric gastroesophageal reflux disease (GERD).

Categories: News, FDA, Clinical, Drugs

Tags: Gastroesophageal Reflux Disease, GERD, Pediatric Drug Development, Draft Guidance

FDA Officials Offer Advice on Efficient Orphan Drug Development By Michael Mezher - Published 17 October 2017

A group of top US Food and Drug Administration (FDA) officials shared insights on how drugmakers can be more efficient when developing treatments for rare diseases, according to comments on Tuesday at the National Organization for Rare Disorders' (NORD) Summit in Washington, DC.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Orphan products

Patient Engagement in Device Trials: FDA Meeting Discusses Challenges and Opportunities By Michael Mezher - Published 16 October 2017

Last week, the US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time to look at ways to increase patient engagement in clinical trials for medical devices.

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

Tags: Patient Engagement, PEAC

EMA Revises Reflection Paper on Pediatric Extrapolation By Michael Mezher - Published 13 October 2017

The European Medicines Agency (EMA) on Friday released an updated draft reflection paper for public consultation detailing the agency's framework for pediatric extrapolation in drug development.

Categories: News, EMA, ICH, Biologics and biotechnology, Clinical, Drugs, Preclinical

Tags: Pediatric Extrapolation

FDA Holds First Patient Engagement Advisory Committee Meeting By Michael Mezher - Published 12 October 2017

The US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time on Wednesday and Thursday to give the agency input from  patients on clinical trials for medical devices.

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

Tags: Patient Engagement, PEAC, Patient Engagement Advisory Committee, Patient Reported Outcomes, Patient Preference Information

Rare Diseases: FDA Awards Grants for 21 Clinical, Natural History Studies By Michael Mezher - Published 06 October 2017

The US Food and Drug Administration (FDA) on Friday awarded $32 million in research grants to fund 15 clinical studies and six natural history studies for rare diseases.

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

Tags: Natural History Studies, Rare Diseases, Orphan Drugs, Grants

ICH Plans Work on Clinical Trials Guideline Revision, Pediatric Extrapolation By Michael Mezher - Published 29 September 2017

The International Council for Harmonisation (ICH) is planning to take up two new topics, according to the minutes released Thursday from the group's meeting in Montreal in May and June.

Categories: News, ICH, Biologics and biotechnology, Clinical, Drugs, Quality

Tags: ICH Assembly, Montreal, E8(R1), Pediatric Extrapolation

European Regulatory Roundup: EMA Overrode Pharma Concerns in Adopting First-in-Human Guideline (28 September 2017) By Nick Paul Taylor - Published 28 September 2017

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

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

Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup

FDA, HHS Finalize Guidance on Documenting IRB Activities By Michael Mezher - Published 25 September 2017

The US Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) on Monday finalized a 2015 draft guidance on how to document institutional review board (IRB) activities.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Medical Devices

Tags: Institutional Review Board, IRB, Minutes, Final Guidance

FDA: 30 Percent of Drugs Used in Expanded Access Programs are Later Approved By Michael Mezher - Published 20 September 2017

A new paper by a team of US Food and Drug Administration (FDA) officials finds that only about 30%of drugs requested for expanded access go on to be approved by the agency.

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

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

Real World Evidence: FDA Commits to Advancing its Use By Zachary Brennan - Published 19 September 2017

To enable greater adoption of real world evidence (RWE) in clinical and regulatory decisions, FDA Commissioner Scott Gottlieb said Tuesday the agency will need to work with the healthcare system to change the way clinical information is collected.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Medical Devices

Tags: real world evidence, Scott Gottlieb, clinical data

FDA Offers Draft Guidance on Organ Preservation Device Animal Studies By Zachary Brennan - Published 15 September 2017

As the national organ transplant waiting list continues to grow and donation and transplant rates remain stagnant, the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help industry with recommendations on best practices for animal studies used to evaluate organ preservation devices.

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

Tags: organ preservation, FDA draft guidance