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Filtering on: "topics medical devices"

Showing 1 – 25  of 1725

Regulatory Recon: Former Lilly Exec Said to be Front Runner for HHS Secretary; Alnylam Partners With Vir on RNAi Hep B Treatment (18 October 2017) By Michael Mezher - Published 18 October 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

How Price Caps in India are Forcing US Device Companies to Sell Stents and Implants at a Loss By Zachary Brennan - Published 18 October 2017

Hypothetical talk circulating on Capitol Hill this week around the idea of price ceilings for certain pharmaceuticals set off alarm bells for industry. But on the medical device side, companies are already seeing what happens when a government, in this case India, sets price caps for certain devices and mandates that companies remain in the market and take a loss on sales.

Categories: News, India, US, MHLW, Government affairs, In vitro diagnostics, Medical Devices, Reimbursement

Tags: stents, knee implants, India price ceilings, medical devices in india

Updated FDA Manual Offers Inside Look at Inspection Protocols By Zachary Brennan - Published 18 October 2017

The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations manual on establishment inspections, offering an inside look at how inspections are conducted and what companies should expect.

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

Tags: FDA inspections, contamination, sterile environments

Regulatory Recon: J&J Halts Two Drugs in Development; Novartis to Close Colorado Manufacturing Site (17 October 2017) By Zachary Brennan - Published 17 October 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

Asia Regulatory Roundup: India Tightens Stem Cell Guidelines (17 September 2017) By Nick Paul Taylor - Published 17 October 2017

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, stem cells, black triangle

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

Regulatory Recon: FDA Reviewers Find Novo's Semaglutide Effective Ahead of Advisory Committee; GSK's Shingles Vaccine Gets First Approval in Canada (16 October 2017) By Michael Mezher - Published 16 October 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Regulatory Recon: House Ethics Report Says Congressman May Have Violated Rules With Australian Biotech Investment; NICE Backs Opdivo for Head and Neck Cancer (13 October 2017) By Michael Mezher - Published 13 October 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

European Regulatory Roundup: Brexit Sparks Hiring Drive at Danish Medicines Agency (12 October 2017) By Nick Paul Taylor - Published 12 October 2017

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

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: European Regulatory Roundup, Brexit

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

Regulatory Recon: Merck Ends Development of CETP Inhibitor; NIH to Team Up With 11 Drugmakers for Immunotherapy Research (12 October 2017) By Michael Mezher - Published 12 October 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Regulatory Recon: Philips to Discontinue US Production of Some Defibrillators; Lupin Buys Symbiomix in $150M Deal (11 October 2017) By Michael Mezher - Published 11 October 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Regulatory Recon: Pfizer Weighs Sale of Consumer Health Business; FDA Releases Briefing Documents for Spark Gene Therapy (10 October 2017) By Michael Mezher - Published 10 October 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

FDA Warns Swedish IVD Manufacturer By Zachary Brennan - Published 10 October 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 20 September to Malmo, Sweden-based Euro Diagnostica AB, which manufactures multiple class II in vitro diagnostic (IVD) devices.

Categories: News, Europe, US, CDRH, Compliance, Due Diligence, In vitro diagnostics, Medical Devices, Quality

Tags: FDA warning letters, IVD manufacturer warning letter, Euro Diagnostica

Regulatory Recon: CA Governor Expected to Sign Drug Price Transparency Bill; China Embraces Foreign Clinical Trial Data to Speed Approvals (9 October 2017) By Michael Mezher - Published 09 October 2017

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

House Bill Calls for New FDA-Led Device Cybersecurity Panel By Michael Mezher - Published 09 October 2017

Republican representatives David Trott (R-MI) and Susan Brooks (R-IN) last week introduced a bill calling for the US Food and Drug Administration (FDA) to lead a new public-private working group on medical device cybersecurity.

Categories: News, US, FDA, Medical Devices

Tags: Cybersecurity

Regulatory Recon: Bayer, J&J's Xarelto Fails Phase III Secondary Stroke Trial; Eli Lilly Beats Alimta Patent Challenge (6 October 2017) By Michael Mezher - Published 06 October 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Regulatory Recon: US Court Reverses Praluent Sales Ban; Study Finds Most New Cancer Drugs Approved by EMA Don't Improve Survival (5 October 2017) By Michael Mezher - Published 05 October 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Regulatory Recon: Grassley Pushes for Drug Pricing Measures in CHIP Reauthorization; US Presses India on Device Price Caps (4 October 2017) By Michael Mezher - Published 04 October 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Canada Reimbursement Profile By Matthew Brougham, MSc, William O'Neil, PhD, Dima Samaha, MAS, PharmD - Published 04 October 2017

This profile summarizes reimbursement processes in Canada, presents information for key stakeholders and highlights what should be considered early in the development process.

Categories: Features, Canada, Health Canada, Drugs, Medical Devices, Reimbursement

Tags: CADTH, Health Canada, INESSS, pCPA, PMPRB

Germany Reimbursement Profile By Elvira Müller, PhD, MPH - Published 03 October 2017

This profile summarizes the reimbursement process in Germany, presents responsibilities for key stakeholders and highlights issues for consideration early in the development process.

Categories: Features, Europe, Drugs, Medical Devices, Reimbursement, Submission and registration

Tags: G-BA, IQWiG, GKV-SV, InEK

Asia Regulatory Roundup: India Orders J&J and Others to Maintain Output of Knee Implants (3 October 2017) By Nick Paul Taylor - Published 03 October 2017

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

Categories: News, Asia, CDSCO, TGA, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, J&J, knee implants

FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions By Michael Mezher - Published 03 October 2017

The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV).

Categories: News, US, FDA, Medical Devices, Submission and registration

Tags: Guidance, MDUFA IV, User Fees, FDA Review Clock, Pre-Submissions, 510(k), PMA, De Novo

Regulatory Recon: Shire Sues Allergan Over Restasis Contracts; Police Search Merck KGaAs French Facility in Thyroid Drug Inquiry (3 October 2017) By Michael Mezher - Published 03 October 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Regulatory Recon: Medicare Spent $1.5B to Replace Faulty Heart Devices; FDA Approves Novo's Fast-Acting Insulin Fiasp (2 October 2017) By Michael Mezher - Published 02 October 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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