Search Results for Zachary Brennan

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FDA Explains Plans to Use Real-World Data in Medical Device Regulatory Decisions By Zachary Brennan - Published 26 July 2016

The US Food and Drug Administration (FDA) on Tuesday released new draft guidance clarifying how it plans to determine cases when real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the standards used to make those decisions.

Categories: News, US, FDA, Clinical, Government affairs, Medical Devices, Postmarket surveillance, Preclinical, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: real-world data, device and real world evidence, device registries, FDA guidance on real world data

FDA Finalizes Guidance on Adaptive Designs for Device Studies By Zachary Brennan - Published 26 July 2016

The US Food and Drug Administration (FDA) on Tuesday finalized guidance that lays out how to design medical device clinical trials that allow for changes based on data, while maintaining study validity and integrity.

Categories: News, US, FDA, Due Diligence, Medical Devices, Research and development

Tags: adaptive trial designs, device clinical trials, final FDA guidance

FDA Lowers ANDA Fee Rates for 2017 By Zachary Brennan - Published 26 July 2016

Generic drugmakers submitting abbreviated new drug applications (ANDAs) and prior approval supplements (PAS) will see their US Food and Drug Administration (FDA) fee rates drop in 2017, though all other rates, including those for drug master files (DMF) and facility fees will increase when compared to 2016.

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance, Generic drugs, Government affairs, Manufacturing, Preclinical, Project management, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: generic drug API manufacturing, GDUFA, generic drug facility fees, FDA fees

FDA Continues Steady Reduction of Generic Drug Application Backlog By Zachary Brennan - Published 25 July 2016

As the debate around high-priced pharmaceuticals and new ways to lower those costs continues, the US Food and Drug Administration (FDA) is speeding the approval of new generic drugs, according to the latest update to the agency’s in-depth look at the backlog of abbreviated new drug applications (ANDAs).

Categories: News, US, FDA, Crisis management, Generic drugs, Due Diligence, Government affairs, Manufacturing

Tags: ANDA backlog, generic drug approval, Woodcock, JAMA

UDI Form and Content: FDA Offers Draft Guidance By Zachary Brennan - Published 25 July 2016

The US Food and Drug Administration (FDA) on Monday released new draft guidance to help define the expected content and forms of the Unique Device Identifier (UDI), to assist both medical device labelers and FDA-accredited issuing agencies in ensuring that UDIs are in compliance with the UDI Rule.

Categories: News, US, FDA, Business and Leadership, Labeling, Medical Devices, Postmarket surveillance, Submission and registration

Tags: unique device identifier, UDI, UDI guidance, FDA draft guidance

Regulatory Recon: Novartis CEO Predicts US Drug Pricing Overhaul; Chinese Scientists to Launch First Human CRISPR Trial (21 July 2016) By Zachary Brennan - Published 21 July 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

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

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

Regulatory Recon: Zika Case in Florida Could be First Locally Acquired Case (20 July 2016) By Zachary Brennan - Published 20 July 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

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

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

FDA Warns GSK’s UK Site for Contamination in API Manufacturing By Zachary Brennan - Published 20 July 2016

The US Food and Drug Administration (FDA) on Wednesday released a warning letter for GlaxoSmithKline’s Worthing, UK-based active pharmaceutical ingredient (API) manufacturing site.

Categories: News, Europe, US, FDA, Active pharmaceutical ingredients, Manufacturing

Tags: GSK, penicillin, API manufacturing

Regulatory Recon: FDA Approves First Extended Depth Lenses for People With Cataracts (18 July 2016) By Zachary Brennan - Published 18 July 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Europe, US, CDSCO, EC, FDA, Health Canada, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

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

European Commission Pushes for Closer Convergence With US on Device Regulations By Zachary Brennan - Published 15 July 2016

As part of the 14th round of ongoing negotiations of the Transatlantic Trade Investment Partnership (TTIP) between the US and EU, the European Commission has released a new proposal that would push for more collaboration on medical device regulations.

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

Tags: UDIs, device regulations, medical devices in EU and US, TTIP

The Next PDUFA: New Performance and Procedural Goals By Zachary Brennan - Published 15 July 2016

Exactly one year after the first round of negotiations over the sixth iteration of the Prescription Drug User Fee Act (PDUFA), the US Food and Drug Administration (FDA) on Friday released the full details of the performance and procedural goals for fiscal years 2018 through 2022.

Categories: News, US, FDA, Business and Leadership, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: PDUFA VI, FDA user fees, FDA performance goals 2016

Regulatory Recon: Congress Takes Summer Vacation Without Addressing Zika (15 July 2016) By Zachary Brennan - Published 15 July 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Canada, Europe, US, CFDA, EC, EMA, FDA, Health Canada, TGA, WHO, Biologics and biotechnology, Drugs, Medical Devices

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

Regulatory Recon: Obama to Sign Opioids Bill; Woodcock on 30 Years at FDA (14 July 2016) By Zachary Brennan - Published 14 July 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Africa, Asia, Canada, Europe, US, CDSCO, EC, EMA, FDA, MHRA, NICE, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices, Product withdrawl and retirement

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

FDA Offers New Draft Guidance on How to Co-Develop IVDs, Therapeutics By Zachary Brennan - Published 14 July 2016

The age of precision medicine, with treatments targeted to specific patients based on a companion test identifying the need for such a treatment, is pushing the US Food and Drug Administration (FDA) to release new and more detailed draft guidance on how companies can co-develop a therapeutic alongside what the agency is calling an in vitro companion diagnostic device, or IVD companion diagnostic.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Government affairs, In vitro diagnostics, Manufacturing

Tags: precision medicine, companion diagnostics, IVDs, therapeutic, genetic tests

ICER to Re-Evaluate How to Assess Value and Comparative Clinical Effectiveness By Zachary Brennan - Published 14 July 2016

The Institute for Clinical and Economic Review (ICER), an independent nonprofit research institute, on Thursday opened a national call for suggestions on how to improve its value assessment framework, which assesses the comparative clinical effectiveness and value of health care tests, treatments and delivery systems.

Categories: News, US, Drugs, Reimbursement

Tags: ICER, comparative effectiveness, evaluating drug costs

House E&C Committee Clears New Priority Review Voucher Program By Zachary Brennan - Published 14 July 2016

The House Energy & Commerce Committee late Wednesday pushed through a bill that will create a new priority review voucher (PRV) program for medical countermeasures that will not sunset.

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

Tags: PRV, priority review voucher, FDA priority review, user fees for priority drug reviews

GAO on Drug Shortages: FDA’s Prioritization of Generic Injectable ANDAs is Helping By Zachary Brennan - Published 13 July 2016

As the number of new drug shortages has generally decreased since 2011, the US Government Accountability Office (GAO) said that although it cannot establish a causal link, the US Food and Drug Administration’s (FDA) prioritization of reviewing hundreds of applications and supplements during the time period GAO examined helped address some shortages.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Government affairs, Manufacturing

Tags: drug shortages, drug manufacturing inspections, generic injectables

Generic Drugs From Four Indian and Chinese Companies Blocked From Entering US By Zachary Brennan - Published 13 July 2016

The US Food and Drug Administration (FDA) on Wednesday added four Chinese and Indian companies to a list of generic drug facilities that are banned from shipping products to the US because they failed to pay fees and meet identification requirements stipulated in the Generic Drug User Fee Amendments of 2012 (GDUFA).

Categories: News, Asia, US, FDA, Compliance, Generic drugs, Manufacturing

Tags: import alert, generic drugs, GDUFA facility fees

Back to Back: FDA Panel Offers Unanimous Thumbs Up for Sandoz’s Enbrel Biosimilar By Zachary Brennan - Published 13 July 2016

For a second straight day, the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee has unanimously pushed for the approval of a new biosimilar, this time for Sandoz’s biosimilar for Amgen’s Enbrel (etanercept).

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

Tags: Sandoz, Novartis, Enbrel, Humira, biosimilars

FDA to Drug Compounders: Inspection Changes Coming in August By Zachary Brennan - Published 12 July 2016

The US Food and Drug Administration (FDA) on Tuesday announced major changes with respect to inspections of drug compounders as infections linked to poor quality drugs continue to crop up.

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

Tags: drug compounding, FDA inspections, drug compounder quality

FDA Panel Unanimously Backs Amgen’s Humira Biosimilar By Zachary Brennan - Published 12 July 2016

The US Food and Drug Administration’s (FDA) Arthritis Advisory Committee on Tuesday voted unanimously to support Amgen’s biosimilar for AbbVie’s blockbuster biologic Humira (adalimumab).

Categories: News, US, FDA, Biologics and biotechnology

Tags: AAC, advisory committee vote, Humira

Senate Pushes Work on ‘Cures’ Legislation Back to September By Zachary Brennan - Published 12 July 2016

The Senate’s version of the House-passed 21st Century Cures Act will not be finished until after the Senate’s summer recess, or September at the earliest, Sen. Lamar Alexander (R-TN) said, confirming rumors that the Senate was struggling to reach agreement on the wide-ranging and heavily criticized legislation.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Medical Devices

Tags: Cures, 21st Century Cures, Alexander, NIH funding

FDA Commissioner Calls for Better National System to Track Device Safety By Zachary Brennan - Published 11 July 2016

The US needs a better system to quickly detect and understand medical device issues when they arise, US Food and Drug Administration (FDA) Commissioner Robert Califf and Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), wrote in a viewpoint published Monday in JAMA.

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance

Tags: Sentinel, device safety, NEST, GAO, Robert Califf

Federal Circuit: Use of a CMO Prior to Filing Drug Patents Does Not Invalidate the Patents By Zachary Brennan - Published 11 July 2016

Pharmaceutical and biotech companies will likely be relieved to hear that the use of a contract manufacturing organization (CMO) cannot cause a drug’s patents to be invalidated under what’s known as the “on sale” bar, according to an opinion released Monday from the US Court of Appeals for the Federal Circuit.

Categories: News, US, Active pharmaceutical ingredients, Drugs, Manufacturing, Project management

Tags: Hospira, Medicines Company, on-sale bar, Federal Circuit

Woodcock: FDA Hits ANDA Backlog Reduction Goal Ahead of Schedule By Zachary Brennan - Published 11 July 2016

Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported on Monday via email that as of 1 July 2016, CDER has acted on more than 90 percent of the Generic Drug User Fee Amendments (GDUFA) backlog, thereby accomplishing the agency’s backlog commitment more than one year ahead of schedule. 

Categories: News, US, CDER, Generic drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: GDUFA, ANDA backlog, generic drug user fees