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Filtering on: "topics research and development"

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What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More By Zachary Brennan - Published 11 December 2017

While recognizing that comparison testing for 510(k) applicants can be outdated, especially for newer medical devices, the US Food and Drug Administration (FDA) announced Monday that in the first quarter of 2018, new draft guidance will be released to address an alternative pathway for demonstrating substantial equivalence.

Categories: News, US, CDRH, Government affairs, In vitro diagnostics, Medical Devices, Research and development

Tags: CDRH guidance, 510(k) alternative pathway, PMA

FDA Backs Off From Regulating Certain Types of Health Software By Zachary Brennan - Published 07 December 2017

The US Food and Drug Administration (FDA) on Thursday unveiled three guidance documents – two draft and one final – that clarify which types of software will be regulated.

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Medical Devices, Research and development

Tags: digital health, health software, 21st Century Cures

Tracking Post-Approval Study Completion: Majority On-Schedule but Not Submitted By Zachary Brennan - Published 07 December 2017

The US Food and Drug Administration (FDA) on Thursday released its most recent report tracking the progress that new drug and biologic applicants are making on post-approval studies.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: post-approval studies, research requirements, post-marketing research

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

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

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

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

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

EU Pediatric Regulation’s 10-Year Anniversary Report Highlights Shortcomings By Zachary Brennan - Published 26 October 2017

Ten years ago, the European Commission created a new regulation as part of an effort to try to encourage more pediatric research.

Categories: News, Europe, EC, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: EU Pediatric Regulation, PIP, pediatric investigation plan

FDA Offers Two Draft Guidances on Drug-Drug Interactions By Zachary Brennan - Published 25 October 2017

The US Food and Drug Administration (FDA) on Wednesday released two draft guidance documents that aim to help drug developers evaluate investigational new drugs for potential drug-drug interactions (DDIs).

Categories: News, US, FDA, Compliance, Drugs, Research and development

Tags: drug-drug interactions, FDA draft guidance, in vitro metabolism

Sandoz Raises Questions With FDA Draft Guidance on Statistical Approaches for Biosimilars By Zachary Brennan - Published 24 October 2017

Martin Schiestl, chief science officer at Novartis' Sandoz, on Tuesday explained how the US Food and Drug Administration's (FDA) draft guidance on statistical approaches to evaluate analytical similarity poses risks that could end up causing true biosimilars to be rejected randomly.

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

Tags: FDA draft guidance, biosimilars, Sandoz

Updated: FDA Releases Flurry of New, Revised Drug-Specific Guidance Documents By Zachary Brennan - Published 19 October 2017

The US Food and Drug Administration (FDA) on Thursday released new draft guidances for 32 drugs, including for those companies looking to develop generic versions of Mylan’s EpiPen (epinephrine) alternative Adrenaclick, Novartis’ cancer treatment Afinitor (everolimus) and AstraZeneca’s cancer treatment Lynparza (olaparib).

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

Tags: FDA guidance, product-specific guidance, generic drug guidance

FDA Seeks Tweaks to Right-to-Try Bill in House E&C Hearing By Zachary Brennan - Published 03 October 2017

The House Energy & Commerce Committee on Tuesday held a hearing to discuss a "Right-to-Try" bill passed in the Senate that the US Food and Drug Administration (FDA) is seeking to change.

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

Tags: Right-to-try, E&C Committee, Gottlieb, GAO, expanded access

Nonclinical Recommendations for Radiopharmaceuticals: FDA Drafts Guidance By Zachary Brennan - Published 12 September 2017

The US Food and Drug Administration (FDA) on Tuesday released draft guidance on nonclinical study recommendations for microdose radiopharmaceutical diagnostic drugs.

Categories: News, US, FDA, Drugs, Government affairs, Preclinical, Research and development

Tags: radiopharmaceuticals, nonclinical recommendations, FDA draft guidance

European Regulatory Roundup: EMA Starts Consultation on Developing Drugs to Meet Needs of Older People (3 August 2017) By Nick Paul Taylor - Published 03 August 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, Regulatory intelligence, Regulatory strategy, Research and development

Tags: European regulatory roundup, drugs for older people, radiopharmaceuticals

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 Publishes 21 New, 13 Revised Draft Generic Drug Guidances Published 13 July 2017

The US Food and Drug Administration (FDA) on Thursday published the 21 new and 13 revised draft guidance documents to help generic drugmakers conduct bioequivalence studies.

Categories: News, US, FDA, Generic drugs, Research and development

Tags: bioequivalence guidance, FDA draft guidance

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

Senate Committee Takes First Step on Rising Pharmaceutical Prices By Zachary Brennan - Published 13 June 2017

The US Senate Health, Education, Labor and Pensions Committee held the first of three hearings on rising pharmaceutical prices Tuesday, discussing the confusing system by which prices are set and possible ways to bring them down.

Categories: News, US, FDA, FTC, Crisis management, Drugs, Government affairs, Regulatory intelligence, Research and development

Tags: Senate HELP, drug prices, Pew, Manhattan Institute, Johns Hopkins, pharmaceutical prices

Researchers Discuss Regulatory Considerations for Tissue-Agnostic Cancer Drugs By Michael Mezher - Published 01 June 2017

In a paper set to be presented at the American Society of Clinical Oncology's annual meeting next week, three oncologists discuss some of the regulatory and scientific considerations for developing "tissue-agnostic" cancer treatments.

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

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

Medicine's Unsung Heroes By Max Sherman - Published 31 May 2017

This article introduces readers to Boyd Woodruff, a legend in the field of microbiology, and discusses his groundbreaking achievements in antibiotic development and Merck's research laboratories.

Categories: Features, US, Drugs, Research and development

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

Doctors Without Borders Appeals Exclusive License Granted to Sanofi for Zika Vaccine By Zachary Brennan - Published 19 May 2017

Doctors Without Borders (MSF) on Friday appealed the US Department of Defense’s decision to grant an exclusive, royalty-bearing license to Sanofi Pasteur for patents to a Zika vaccine developed with US government funds.

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

Tags: Doctors Without Borders, MSF, Zika vaccine, Sanofi

Biopharma Companies Take Issue With FDA's Draft Biosimilar Interchangeability Guidance By Zachary Brennan - Published 18 May 2017

Ahead of Friday's deadline for comments, a number of biopharmaceutical companies are seeking further clarification from the US Food and Drug Administration (FDA) on various aspects of the draft biosimilar interchangeability guidance.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Labeling, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development

Tags: biosimilars, interchangeability, FDA draft guidance, biosimilar guidance