Search Results for

Filtering on: "topics research and development"

Showing 1 – 25  of 215

Politicizing the FDA: What the Trump Win Means for New Pharma Regulations By Zachary Brennan - Published 19 January 2017

President-Elect Donald Trump on Friday will become the 45th US president and though he’s yet to name his choice for commissioner of the US Food and Drug Administration (FDA), the names of those floated to lead the agency and a recent flood of new draft and finalized FDA guidance reveal an agency bracing for change.

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

Tags: Trump, FDA, FDA commissioner pick, Rob Califf

Insulin: The First Truly Miracle Drug By Max Sherman - Published 08 December 2016

This article will discuss diabetes, the process of the discovery of insulin and provide brief biographies of two intrepid people involved.

Categories: Features, Canada, Biologics and biotechnology, Research and development

Tags: Diabetes, Insulin, Drug Discovery

FDA Says Real-World Evidence Could Generate 'Incorrect or Unreliable Conclusions’ By Zachary Brennan - Published 08 December 2016

Fifteen top US Food and Drug Administration (FDA) officials published an article in the New England Journal of Medicine on Thursday calling into question some of the potential uses of real-world evidence (RWE) but also acknowledging that real world research and the concepts of a planned intervention and randomization “are entirely compatible."

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: 21st Century Cures, real-world evidence, real-world data and pharmaceuticals

House to Pass Revamped 21st Century Cures Bill By Zachary Brennan - Published 30 November 2016

The US House of Representatives on Wednesday is poised to pass a wide-ranging bill that will overhaul certain aspects of the US Food and Drug Administration (FDA) and provide the agency with more funding.

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

Tags: 21st Century Cures, #CuresNow, Cancer Moonshot, FDA legislation, lame duck session

FDA Finalizes Guidance on Providing Postmarket Safety Reports in ICH Format By Zachary Brennan - Published 29 November 2016

The US Food and Drug Administration (FDA) on Tuesday finalized guidance describing the conditions under which companies can use an alternative reporting format to satisfy postmarketing safety reporting requirements.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Due Diligence, Quality, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: ICH guidance, PSUR, PAER, PADER, PBRER

FDA Withdraws Proposed Rule on Public Disclosure of Info on Unapproved Gene Therapies By Zachary Brennan - Published 10 November 2016

The US Food and Drug Administration (FDA) on Thursday announced it is withdrawing a proposed rule from 2001 that would have required the public disclosure of summaries of safety and effectiveness data, in addition to other information, from pre-market clinical trials of gene therapies and transplanted non-human tissues to humans, known as xenotransplantation.

Categories: News, US, CBER, Biologics and biotechnology, Clinical, Crisis management, Due Diligence, Government affairs, Human cell and tissue, Preclinical, Research and development

Tags: gene therapy, xenotransplantation, BIO, Public Citizen

RAPS Regulatory Convergence - 2016 Hot Topic Review By Sara Bobbit - Published 09 November 2016

This article provides a round-up of hot topics presented at this year's RAPS Regulatory Convergence and includes a high level recap of several sessions covering innovation and technology, Zika, real world evidence, patient access to innovative medicines and recent developments in off-label promotion.

Categories: News, Japan, Europe, US, FDA, MHLW, PMDA, Advertising and Promotion, Biologics and biotechnology, Clinical, Communication, Drugs, Labeling, Medical Devices, Research and development, Submission and registration

Tags: Regulatory Convergence, 2016 RAPS

Draft CFDA Guidance on Drug Data Management Practices By Yingying Liu, Siegfried Schmitt - Published 31 October 2016

The China Food and Drug Administration (CFDA) has recently issued a new draft guidance document on data integrity, covering the entire data lifecycle from R&D to commercial production and distribution. This article is a translation of the summary of the draft guidance.

Categories: News, China, CFDA, Clinical, Manufacturing, Preclinical, Research and development

Tags: Data Management

FDA Approves First PFO Occluder From St. Jude By Zachary Brennan - Published 28 October 2016

The US Food and Drug Administration (FDA) on Friday approved Minnesota-based St. Jude Medical’s Amplatzer PFO Occluder, which is intended to reduce the risk of a stroke for some patients who previously had a stroke.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: PFO Occluder, St. Jude Medical, FDA device approval

EMA Prioritizes Three New Treatments as Part of its PRIME Scheme By Zachary Brennan - Published 19 October 2016

The European Medicines Agency (EMA) on Wednesday announced that it recently granted eligibility to three new treatments as part of its PRIME scheme, which focuses on medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.

Categories: News, Europe, EMA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Research and development

Tags: PRIME, priority medicines, oncology

ICER on PD-1 Immunotherapies to Treat Lung Cancer: Lower the Prices By Zachary Brennan - Published 03 October 2016

In a new report on non-small cell lung cancer (NSCLC) treatments, the Institute for Clinical and Economic Review (ICER) found that for PD-1 immunotherapies, which are also often used to treat melanoma, the cost may be too high in terms of lengthening progression-free and overall survival.

Categories: News, US, Biologics and biotechnology, Due Diligence, Ethics, Regulatory strategy, Reimbursement, Research and development

Tags: NSCLC, lung cancer, ICER

510(k) Third Party Review Program: FDA Offers New Draft Guidance By Zachary Brennan - Published 09 September 2016

The US Food and Drug Administration (FDA) on Friday issued new draft guidance updating the agency’s current thinking on a program used to accredit third parties to review premarket notification (510(k)) submissions for medical devices and recommend the initial classification of certain devices.

Categories: Canada, Europe, US, CDRH, Health Canada, IMDRF, MHLW, TGA, Government affairs, Manufacturing, Medical Devices, Research and development

Tags: 510(k) submissions, medical devices, third-party audits of medical devices, IMDRF, MDSAP

FDA, EMA, PMDA Begin Push for New Antibacterials By Michael Mezher - Published 08 September 2016

The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) met at EMA headquarters in London last week to discuss their role in promoting the development of new antibacterial products.

Categories: News, Japan, Europe, US, EMA, FDA, PMDA, Clinical, Drugs, Preclinical, Regulatory strategy, Research and development

Tags: Antimicrobial resistance, AMR

Biosimilar Interchangeability: ‘Careful What You Wish For’ By Zachary Brennan - Published 08 September 2016

As the open question around interchangeable biosimilars in the US continues to drive the discussion on what the US Food and Drug Administration (FDA) will require for such a designation, some experts are saying the designation might not actually be that important for the biosimilar market as a whole.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Crisis management, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: interchangeability, biosimilars, biologics and biosimilars, Momenta Pharmaceuticals, Pfenex, Sandoz, GPhA

Japan’s Ministry of Foreign Affairs: Don’t Move EMA Headquarters From London By Zachary Brennan - Published 06 September 2016

If the European Medicines Agency (EMA) transfers its headquarters to another EU member state, which is all but certain following the Brexit vote, Japan’s Ministry of Foreign Affairs is warning that the “appeal of London as an environment for the development of pharmaceuticals would be lost.”

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

Tags: EMA, Brexit, UK approval of drugs

FDA Begins Process of Overhauling Off-Label Communications Regulations By Zachary Brennan - Published 31 August 2016

The US Food and Drug Administration (FDA) on Wednesday announced a new two-day public meeting to address a comprehensive review of its regulations and policies governing firms’ off-label communications on unapproved uses of approved drugs and medical devices.

Categories: News, US, FDA, FTC, Biologics and biotechnology, Business and Leadership, Compliance, Drugs, Ethics, Government affairs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: pharmaceutical off-label communications, Amarin, drug company free speech

FDA Finalizes Guidance on Microbiology Data for Antibacterials By Michael Mezher - Published 29 August 2016

The US Food and Drug Administration (FDA) on Friday finalized guidance intended to help drugmakers prepare the data necessary to support the approval of new antibacterial drugs.

Categories: News, US, FDA, Clinical, Drugs, Preclinical, Research and development

Tags: Antibacterial, Antimicrobial resistance, Microbiology data, Final guidance

Approval of Anthrax Vaccine Under FDA’s Animal Rule is a Step Forward, Researchers Argue By Zachary Brennan - Published 25 August 2016

Although the US Food and Drug Administration’s (FDA) 2015 approval of the vaccine BioThrax for postexposure prophylaxis (PEP) for inhalational anthrax wasn’t the first approval under the rarely used Animal Rule, researchers in Nature explained on Thursday why it is a “significant step forward” in the approval of new vaccines and other medical countermeasures under the pathway.

Categories: News, Canada, Europe, US, FDA, Biologics and biotechnology, Clinical, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: Animal Rule, Nature, Accelerated Approval, Ebola, Anthrax, medical countermeasures

Cancer Immunotherapies: EMA to Hold November Workshop By Zachary Brennan - Published 16 August 2016

The European Medicines Agency (EMA) on Tuesday announced that its Committee for Advanced Therapies (CAT) is organizing a workshop on 15 and 16 November 2016 to discuss the scientific and regulatory challenges of immunotherapy medicines based on genetically modified T-cells (white blood cells that fight off viruses and bacteria).

Categories: News, Europe, US, EMA, FDA, Business and Leadership, Clinical, Human cell and tissue, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: CAR T, CAR T-cell therapies, immuno-oncology, immunotherapy, EMA workshop on immunotherapies

FDA Offers First Major Update to ‘Orange Book’ Website By Zachary Brennan - Published 15 August 2016

The US Food and Drug Administration (FDA) on Monday launched an improved web-based version of its publication on drugs approved on the basis of safety and effectiveness, more commonly known as the “Orange Book.”

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

Tags: Orange Book, list of generic drugs from FDA, FDA list of drugs

3D Medical Device Printing: Industry Seeks More Clarity From FDA By Zachary Brennan - Published 15 August 2016

Medical device manufacturers are looking to coax the US Food and Drug Administration (FDA) into providing more clarity on its guidance on 3D printing, according to comments released last Friday.

Categories: News, US, FDA, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: 3D printing of medical devices, 3D devices, additive manufacturing

European Regulatory Roundup: UK Lord Tries to Reassure Politicians on Brexit Life Science Strategy (11 August 2016) By Nick Paul Taylor - Published 11 August 2016

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

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

Tags: European Regulatory Roundup, Brexit, immunotherapy, mAb

Regulatory Explainer: Everything You Need to Know About Biosimilars By Zachary Brennan - Published 10 August 2016

For more than a decade now, biotech and pharmaceutical companies have brought a new class of treatments – biosimilars – to markets around the world (from the EU to India to South Korea to the US), offering cost savings for some of the most expensive medicines, though even in 2016, decades after companies began their quest to develop biosimilars, they are still only just beginning to see widespread adoption.

Categories: News, Africa, Asia, Europe, US, CDSCO, EMA, FDA, FTC, Health Canada, MHRA, Biologics and biotechnology, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: biosimilars, BPCIA, patent dance, biologics, biosimilar savings

FDA, Health Canada Look to Implement Common Electronic Submission System By Zachary Brennan - Published 09 August 2016

As part of efforts to further align the US Food and Drug Administration (FDA) and Health Canada, both sides are working to implement a common electronic submission gateway to allow pharmaceutical companies to submit large electronic documents simultaneously to both regulators.

Categories: News, Canada, US, FDA, Health Canada, Drugs, Ethics, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: mutual recognition of GMP assessments, pharmaceutical regulatory sharing, drug regulators

Califf: Advances in Cardiology Will be Made by Integrating New Data Sources and Technologies By Michael Mezher - Published 09 August 2016

US Food and Drug Administration (FDA) Commissioner Robert Califf is calling on cardiologists to embrace new technologies and data sources, such as genetic sequencing, regenerative medicine, personal electronic devices and social media, in order to improve patient outcomes moving forward.

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

Tags: Cardiology, Robert Califf