Search Results for Zachary Brennan

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UK’s MHRA Unveils Human Factors Guidance for Medical Devices By Zachary Brennan - Published 19 September 2017

As part of its work to minimize the risks from use error and promote safe practices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released new guidance on human factors and usability engineering for medical device manufacturers.

Categories: News, Europe, EC, MHRA, Combination products, Government affairs, In vitro diagnostics, Medical Devices

Tags: human factors guidance for medical devices, MHRA guidance, MDR

FDA Warns Korean, Chinese Drugmakers By Zachary Brennan - Published 19 September 2017

The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent recently to Korea-based Firson Co. and China's Wuxi Medical Instrument Factory detailing the firms' violations.

Categories: News, Asia, US, FDA, Drugs, Manufacturing

Tags: FDA warning letters, Wuxi Medical, Firson

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

Regulatory Recon: Phase III Cancer Vaccine Trial Fails; EMA’s CHMP Recommends 13 Medicines for Approval (15 September 2017) By Zachary Brennan - Published 15 September 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Malaysia Issues Compulsory License for Gilead Hepatitis C Drug By Zachary Brennan - Published 15 September 2017

Late last month, Malaysia’s government issued a compulsory license in an effort to offer a less-expensive version of Gilead’s hepatitis C drug and increase access.

Categories: News, Asia, Drugs

Tags: Malaysia, Gilead, Hepatitis C, compulsory license

FDA Offers Draft Guidance on Organ Preservation Device Animal Studies By Zachary Brennan - Published 15 September 2017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

House Reps Seek More Transparency on Novartis-CMS Pricing Deal for Newly Approved CAR-T Therapy By Zachary Brennan - Published 14 September 2017

Rep. Lloyd Doggett (D-TX) and other House Democrats on Wednesday sent a letter to Seema Verma, administrator of the Centers for Medicare & Medicaid Services (CMS), seeking to find out more information about an outcomes-based payment approach for Novartis’ newly approved chimeric antigen receptor T-cell (CAR-T) treatment Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).

Categories: News, US, Compliance, Reimbursement

Tags: CAR-T, outcomes-based deal, Novartis

FDA Unveils Higher PDUFA, Lower BsUFA Fees for FY 2018 By Zachary Brennan - Published 14 September 2017

With the new user fee deals signed into law, the US Food and Drug Administration (FDA) on Wednesday unveiled the revamped fee amounts that will apply from 1 October 2017 to 30 September 2018 for prescription drug and biosimilar application and programs.

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

Tags: BsUFA, PDUFA, FDA user fees 2018

FDA Transparency: Gottlieb Outlines What’s Coming By Zachary Brennan - Published 14 September 2017

FDA Commissioner Scott Gottlieb has been at the forefront of the Washington, D.C. conference circuit this week discussing new work that the agency he leads will undertake, with discussions Thursday at a Politico event, a speech Wednesday at the Friends of Cancer Research, a speech Monday at RAPS' Convergence and a speech last week at the National Health Research Forum.

Categories: News, US, FDA, Drugs, Government affairs

Tags: Scott Gottlieb, CRL transparency, REMS

FDA Approves First Biosimilar Cancer Treatment By Zachary Brennan - Published 14 September 2017

The US Food and Drug Administration (FDA) on Thursday approved Amgen’s biosimilar to Roche’s cancer treatment Avastin (bevacizumab). Amgen's biosimilar was approved under the brand name Mvasi (bevacizumab-awwb).

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Submission and registration

Tags: Amgen, Mvasi, Avastin biosimilar

Interchangeable Biosimilars vs. Biosimilars: Experts Explain Guidance, Discuss Development and Uptake By Zachary Brennan - Published 13 September 2017

Interchangeable biosimilars are headed to the US market over the next several years and discussion of the incoming products kicked off both the Biosimilars Council's conference on Wednesday and RAPS' Regulatory Convergence on Monday.

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

Tags: biosimilars, interchangeable biosimilars

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

FDA to Close Loophole Allowing Companies to Skirt Pediatric Study Requirements By Zachary Brennan - Published 12 September 2017

FDA commissioner Scott Gottlieb announced Tuesday that the agency will release guidance to close a loophole that allows companies to avoid their obligation to study pharmaceuticals in pediatric populations.

Categories: News, US, FDA, Clinical, Drugs

Tags: FDARA, PREA, pediatric clinical trials

Gottlieb Targets Drug Development Costs, Clinical Development Efficiencies By Zachary Brennan - Published 11 September 2017

FDA commissioner Scott Gottlieb on Monday explained to attendees of RAPS’ Regulatory Convergence conference some steps FDA is taking to make the clinical end of drug development more efficient and effective.

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

Tags: Scott Gottlieb, FDA commissioner, clinical development

CDRH to Launch 'Critical to Quality' Pilot Program By Zachary Brennan - Published 11 September 2017

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will lead a pilot program to define characteristics of a device that are critical to product quality and how these characteristics are controlled in design and manufacturing prior to the postmarket inspection.

Categories: News, US, CDRH, Medical Devices

Tags: Critical to Quality, FDA pilot program

Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds By Zachary Brennan - Published 08 September 2017

The US Food and Drug Administration (FDA) is increasingly granting faster reviews via expedited regulatory pathways, but a new article published in the British Medical Journal found an association between these expedited pathways and the likelihood of safety-related labeling changes.

Categories: News, US, FDA

Tags: breakthrough drug, accelerated approval, fast track, drug safety, label changes

FDA Wants to Know What Regulations and Paperwork Requirements Need to Go By Zachary Brennan - Published 07 September 2017

As part of work under two executive orders, the US Food and Drug Administration's (FDA) centers on Thursday sought comments on which existing regulations and related paperwork requirements could be modified, repealed or replaced, to reduce the burden on industry while allowing FDA to continue its public health mission and fulfill statutory obligations.

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

Tags: FDA regulations, paperwork reduction, one in, two out

CDRH Releases 8 Warning Letters for Foreign, US Device Manufacturers By Zachary Brennan - Published 06 September 2017

About a week after the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) was criticized for sending a historically low number of warning letters so far in 2017, a flood of new letters were released Wednesday.

Categories: News, Asia, Europe, US, CDRH, Manufacturing, Medical Devices

Tags: warning letters, medical device warnings

Updated: FDA Form 483 for Celltrion May Offer a Glimpse Into Limited Uptake for Remicade Biosimilar By Zachary Brennan - Published 06 September 2017

The US Food and Drug Administration (FDA) on Wednesday released a Form 483 sent to Korea’s Celltrion with 12 observations, which an industry analyst believes could be the reason why the commercialization of Celltrion and Pfizer’s Inflectra (infliximab-dyyb), a biosimilar to Remicade, has not gone as well as planned in the US.

Categories: News, Asia, US, FDA, Biologics and biotechnology, Crisis management

Tags: Celltrion, Form 483, Pfizer, Inflectra

FDA Finalizes Guidance on Deviation Reporting for HCT/Ps By Zachary Brennan - Published 06 September 2017

The US Food and Drug Administration (FDA) on Wednesday finalized guidance to help manufacturers of non-reproductive human cells, tissues and cellular and tissue-based products (HCT/Ps) understand the agency’s recommendations and relevant examples for complying with the requirements to investigate and report HCT/P deviations.

Categories: News, US, FDA, Biologics and biotechnology, Human cell and tissue

Tags: HCT/Ps, human tissues, FDA final guidance

Help Wanted: FDA Seeks Digital Health Entrepreneurs By Zachary Brennan - Published 06 September 2017

Details of how the US Food and Drug Administration (FDA) is planning to tackle the growing digital health industry are slowly trickling out and on Wednesday the agency announced it will establish an Entrepreneur-in-Residence (EIR) Program to support and help develop its Software Precertification (PreCert) Pilot Program.

Categories: News, US, FDA, Government affairs, Medical Devices

Tags: digital health and FDA, precertification pilot

The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren’t Yet Biosimilars in the US By Zachary Brennan - Published 05 September 2017

Why has the European Medicines Agency (EMA) approved follow-on insulin products as biosimilars while the US Food and Drug Administration (FDA) has not? A look at several recent examples shows what is happening and what will change in the US over the next several years.

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

Tags: insulin, Merck, Lilly, Sanofi, Admelog, 505(b)(2), biosimilars

FDA Finalizes Guidance on Interoperable Devices By Zachary Brennan - Published 05 September 2017

The US Food and Drug Administration (FDA) on Tuesday finalized guidance outlining recommendations on how medical devices should be able to securely interact with other devices and information systems.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: interoperable medical devices, EHRs and devices

WHO to Launch Pilot to Prequalify Biosimilars By Zachary Brennan - Published 05 September 2017

The World Health Organization (WHO) announced Tuesday that in October it will launch a pilot project for prequalifying biosimilars as part of its work to make some of the most expensive treatments for cancer more widely available in low- and middle-income countries.

Categories: News, WHO, Biologics and biotechnology, Drugs

Tags: biosimilar prequalification, WHO prequalification

E-Submissions of REMS Documents: FDA Offers Draft Guidance By Zachary Brennan - Published 01 September 2017

The US Food and Drug Administration (FDA) on Friday released draft guidance describing how it plans to implement requirements for the electronic submission of Risk Evaluation and Mitigation Strategies (REMS) documents in certain submissions under new drug applications, abbreviated new drug applications and biologics license applications.

Categories: News, US, FDA, Drugs

Tags: REMS, e-submissions FDA