Search Results for

Filtering on: "topics postmarket surveillance"

Showing 1 – 25  of 392

EMA Plots Out Priorities to Deal With Brexit Uncertainties By Zachary Brennan - Published 16 October 2017

The European Medicines Agency (EMA) on Monday released its Brexit Preparedness Business Continuity Plan, saying it will prioritize its core scientific activities, including urgent and significant public health threats relating to the safety and quality of medicinal products for human and veterinary use in the EU.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Crisis management, Drugs, Postmarket surveillance

Tags: Brexit, EMA business continuity

EMA Responds to BMJ Article Questioning Benefits of Recent Cancer Drug Approvals By Zachary Brennan - Published 13 October 2017

As more cancer drugs are approved and prices continue to rise, questions have circulated on whether these drugs are extending patient survival or improving quality of life (QoL).

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: cancer drug approvals, QoL, survival benefit

EMA Makes Final Preparations Ahead of New EudraVigilance Launch By Michael Mezher - Published 04 October 2017

With the 22 November launch date for its revamped EudraVigilance system rapidly approaching, the European Medicines Agency (EMA) on Wednesday provided some last minute updates on what to expect during the transition to the new system.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Postmarket surveillance

Tags: EudraVigilance, Pharmacovigilance, ICSRs, SUSARs, Adverse Event Reporting

IMDRF Consults on Use of Registries to Support Device Approval Decisions By Zachary Brennan - Published 02 October 2017

The International Medical Device Regulators Forum (IMDRF) has opened for consultation until 1 December a third document on examining the use of registries to support medical device regulatory decision making.

Categories: News, Asia, Canada, Europe, US, IMDRF, In vitro diagnostics, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: registry data and medical devices, medical device data, approval decisions and registries

FDA Launches Searchable Adverse Event Database for Drugs and Biologics By Michael Mezher - Published 29 September 2017

The US Food and Drug Administration (FDA) on Wednesday launched a new searchable public dashboard for its adverse event database for drugs and biologics.

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

Tags: FAERS, Public Dashboard, Adverse Event Reports

Making Sense of FAERS: Researchers Suggest Fixes to FDA's Adverse Event Database By Michael Mezher - Published 29 August 2017

A team of researchers from Novartis, Oracle Health Sciences and the University of California, San Francisco say the US Food and Drug Administration's (FDA) adverse drug reaction database could be improved by grouping drugs by their chemical structure and automating certain reporting functions.

Categories: News, US, FDA, Drugs, Postmarket surveillance

Tags: FAERS, Adverse Drug Reactions, ADRs, Pharmacovigilance

EMA Reports Rise in Pharmacovigilance Inspections in 2016 By Michael Mezher - Published 08 August 2017

In a report released on Tuesday, the European Medicines Agency (EMA) said the number of pharmacovigilance inspections for centrally authorized products rose in 2016, mainly driven by an increase in routine inspections carried out under national inspection programs.

Categories: News, Europe, EMA, Biologics and biotechnology, Compliance, Drugs, Postmarket surveillance

Tags: Pharmacovigilance, Pharmacovigilance Inspections

FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics By Zachary Brennan - Published 08 August 2017

As the number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Postmarket surveillance

Tags: BLA, CMC changes, postapproval manufacturing changes, FDA draft guidance

European Regulatory Roundup: EU Watchdog Probes Whether Pre-Submission Meetings Enable Industry to Influence EMA (20 July 2017) By Nick Paul Taylor - Published 20 July 2017

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

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Postmarket surveillance, Submission and registration

Tags: EU Regulatory Roundup

Report Calls on FDA to Adopt New Standard for Reviewing Opioids By Michael Mezher - Published 14 July 2017

The National Academies of Sciences, Engineering and Medicine (NASEM) issued a report Thursday calling on the US Food and Drug Administration (FDA) to change its approach to reviewing opioids in light of the ongoing opioid epidemic.

Categories: News, US, FDA, Clinical, Drugs, Postmarket surveillance, Submission and registration

Tags: Opioids, Opioid Epidemic

FDA Considers Label Changes for Keytruda, Opdivo and Yervoy By Zachary Brennan - Published 12 July 2017

The US Food and Drug Administration (FDA) told Focus on Wednesday that the agency is considering labeling changes to include additional ocular inflammatory conditions for three immune checkpoint inhibitors.

Categories: News, US, FDA, Drugs, Postmarket surveillance

Tags: Opdivo, Keytruda, Yervoy, B-MS, Merck, uveitis

EMA Restricts Use of Biogen MS Drug By Zachary Brennan - Published 07 July 2017

The European Medicines Agency (EMA) on Friday announced it is provisionally restricting the use of Biogen Idec’s multiple sclerosis (MS) medicine Zinbryta (daclizumab) to patients "with highly active relapsing disease that has failed to respond to certain other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines."

Categories: News, Europe, EMA, FDA, Drugs, Labeling, Postmarket surveillance

Tags: Biogen, MS, EMA PRAC

FDA Delays Enforcement of Product Identifier Requirements By Zachary Brennan - Published 30 June 2017

In a draft guidance published Friday, the US Food and Drug Administration (FDA) says it does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before 26 November 2018.

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

Tags: DSCSA, track and trace, FDA draft guidance

Fears Over Device Surveillance Amid Talk of Deregulation By Michael Mezher - Published 30 June 2017

A team of researchers say that better postmarketing data for medical devices could identify safety issues sooner, but they fear that current political headwinds could derail planned device safety efforts.

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

Tags: Power Morcellators, Postmarketing Studies, Postmarket Surveillance, NEST

Health Canada Opens Consultation on Mandatory Adverse Drug Reaction, Device Incident Reports By Zachary Brennan - Published 28 June 2017

Health Canada on Tuesday opened up a consultation on changes to the country's Food and Drug Regulations and Medical Devices Regulations that would make it mandatory for certain health care institutions to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs).

Categories: News, Canada, Health Canada, Drugs, Government affairs, Medical Devices, Postmarket surveillance

Tags: Health Canada, Vanessa's Law, adverse event reporting

AdvaMed Urges Supreme Court to Take Up Case on 510(k) Review Process By Zachary Brennan - Published 27 June 2017

Does a medical device cleared under the US Food and Drug Administration's 510(k) review process mean that it is safe or that the device is just "substantially equivalent" to a legally marketed device? That's the question industry group AdvaMed wants the US Supreme Court to answer.

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

Tags: SCOTUS, Supreme Court, AdvaMed, 510(k)

EMA Offers New EudraVigilance Checklist for Sponsors, MAHs By Zachary Brennan - Published 26 June 2017

The European Medicines Agency (EMA) on Monday published a checklist to help marketing authorization holders (MAHs) and sponsors prepare for the technical changes ahead of the launch of the new EudraVigilance adverse event system on 22 November 2017.

Categories: News, Europe, EMA, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: EudraVigilance, marketing authorisation holders, individual case safety reports

European Regulatory Roundup: EMA Tasks Working Groups With Redistributing Workloads in Run Up to Brexit (22 June 2017) By Nick Paul Taylor - Published 22 June 2017

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

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Drugs, Medical Devices, Postmarket surveillance

Tags: European Regulatory Roundup, Regulatory Roundup

FDA Offers Updated Form for Field Alert Reports By Michael Mezher - Published 16 June 2017

The US Food and Drug Administration (FDA) on Thursday released an updated version of its automated Field Alert Report (FAR) form, following the conclusion of a successful four-year pilot program.

Categories: News, US, FDA, Generic drugs, Prescription drugs, Postmarket surveillance

Tags: FAR, Field Alert Reports

FDA to Take Closer Look at Abuse-Deterrent Opioids By Michael Mezher - Published 13 June 2017

The US Food and Drug Administration (FDA) on Tuesday announced its next move in addressing the ongoing opioid abuse epidemic will be to take a closer look at the data supporting abuse-deterrent labeling for opioids.

Categories: News, US, Drugs, Labeling, Postmarket surveillance

Tags: Opioids, Abuse-Deterrent Opioids

Asia Regulatory Roundup: CFDA Ordered More Inspections of Foreign Manufacturers in 2016, But Visited Fewer Sites (6 June 2017) By Nick Paul Taylor - Published 06 June 2017

The China Food and Drug Administration (CFDA) has released a breakdown of the good manufacturing practice (GMP) inspections it performed last year. The report shows another year of growth in the number of inspections of overseas manufacturers ordered by CFDA, yet the agency only performed a fraction of these planned visits.

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance

Tags: Regulatory Roundup, Asia Regulatory Roundup

ICD and Pacemaker Ecosystems Vulnerable to Hacks: Report By Michael Mezher - Published 05 June 2017

Cybersecurity firm WhiteScope says it has identified cybersecurity vulnerabilities in the device ecosystems for pacemakers and implantable cardioverter-defibrillators (ICDs) across four major vendors.

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

Tags: Cybersecurity, Pacemakers, ICDs, Billy Rios, WhiteScope, DHS ICS-CERT

European Regulatory Roundup: EU Device Regulations Come Into Force; Swissmedic Clarifies Pharmacovigilance Process (1 June 2017) By Nick Paul Taylor - Published 01 June 2017

The European Union medical device and in-vitro diagnostic (IVD) regulations have come into force. The passing of the date marks the start of the phased, multi-year introductions of requirements set out in the two documents.

Categories: Europe, EC, EMA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Postmarket surveillance, Submission and registration

Tags: European Regulatory Roundup, Regulatory Roundup, EU Regulatory Roundup, Brexit, MDR, IVDR, Swissmedic, Pharmacovigilance,

Swissmedic Touts 2016 Performance: 42 New Approvals By Michael Mezher - Published 30 May 2017

In its annual report released Tuesday, Swiss drug regulator Swissmedic says it outpaced the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in approving new drugs in 2016, in part due to the agency's new fast-track procedure.

Categories: News, Europe, Biologics and biotechnology, Drugs, Postmarket surveillance, Submission and registration

Tags: Swissmedic, new active substance, New chemical entity, fast track

EMA to Launch Revamped EudraVigilance System to Monitor Adverse Events By Zachary Brennan - Published 22 May 2017

The European Medicines Agency’s (EMA) management board on Monday endorsed the launch on 22 November 2017 of an improved system for collecting and monitoring suspected adverse events.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: EudraVigilance, ICSR, adverse events, marketing authorisation holders