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Filtering on: "topics postmarket surveillance"

Showing 1 – 25  of 362

FDA Warns Teva API Plant in China By Zachary Brennan - Published 25 April 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 10 April to Teva for deficiencies related to an active pharmaceutical ingredient (API) manufacturing site in Hangzhou, China.

Categories: News, US, FDA, Active pharmaceutical ingredients, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: Teva, warning letter, FDA inspections

IMDRF Offers New Guideline on Adverse Event Reporting By Zachary Brennan - Published 10 April 2017

As a way to improve the accuracy and capture of medical device adverse events, the International Medical Device Regulators Forum (IMDRF), a voluntary and global group of device regulators, on Monday published a new final guideline on a harmonized terminology for reporting such events.

Categories: News, Asia, Canada, Europe, US, IMDRF, Compliance, In vitro diagnostics, Medical Devices, Postmarket surveillance, Quality

Tags: adverse events for medical devices, IMDRF guideline, GHTF

EMA Completes Postmarket Safety Review of Uptravi By Michael Mezher - Published 07 April 2017

Less than two months after launching a safety review of Actelion Pharmaceuticals' pulmonary arterial hypertension (PAH) drug, Uptravi (salexipag), the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) says it did not find an increased risk of death associated with the drug.

Categories: News, Europe, EMA, Prescription drugs, Postmarket surveillance

Tags: Uptravi, salexipag, PRAC

EU Parliament Adopts New Medical Device, IVD Regulations By Michael Mezher - Published 05 April 2017

The EU's effort to overhaul the regulation of medical devices and in vitro diagnostics (IVDs) has cleared its final legislative hurdle after the European Parliament on Wednesday adopted the proposed regulations without amendment, voting down a proposal from the UK Independence Party to reject the regulations.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices, Postmarket surveillance, Submission and registration

Tags: MDR, IVDR, European Parliament

Diagnostics: Bipartisan Duo Offers Bill to Alter Regulations By Zachary Brennan - Published 27 March 2017

The ongoing overhaul of diagnostic and lab-developed test (LDT) regulations turned another corner last week, with Reps. Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) releasing a discussion draft of a bill that would offer a new direction for the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS).

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Medical Devices, Postmarket surveillance, Research and development

Tags: diagnostics, IVDs, IVCT, in vitro clinical test, LDT, lab-developed test

Establishing a Joint Venture Pharmaceutical Manufacturing Entity in Japan By Satoshi Koike, PhD, DSc - Published 23 March 2017

This article focuses on key regulatory activities to establish a Joint Venture (JV) for pharmaceutical manufacturing and sales in Japan. The author describes foundation building, marketing authorization holder responsibilities, new drug applications, clinical trial sponsorship, adverse events reporting and brand name registrations as well as requirements for data archiving and post-marketing regulatory activities.

Categories: Features, Japan, MHLW, PMDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance, Submission and registration

Tags: Common Technical Document, CTD

Fast Facts: Serious Adverse Event Reporting Requirements in the US By Valerie Fauvelle, MS, RAC - Published 22 March 2017

This article presents reporting requirements for Serious Adverse Events (SAEs) and focuses on an important, but often overlooked regulation that specifies when a study is being run and includes the use of an approved drug. There are reporting requirements with specific timeframes that must be followed if there is a reportable SAE attributed to the approved drug.

Categories: Features, US, FDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance

Tags: Adverse Event Reporting

Asia Regulatory Roundup: India Proposes Platform to Monitor Drug Supply Chain (21 March 2017) By Nick Paul Taylor - Published 21 March 2017

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

Categories: News, Asia, CDSCO, TGA, Biologics and biotechnology, Drugs, Government affairs, Postmarket surveillance

Tags: Asia regulatory roundup, India drug supply, TGA pharmacovigilance

MHRA Releases Recommendations for Leadless Pacemakers By Michael Mezher - Published 16 March 2017

The UK's Medicines and Healthcare products Regulatory Agency's expert advisory group on leadless cardiac devices has released its initial recommendations for pre- and postmarket clinical studies for leadless pacemakers.

Categories: News, Europe, MHRA, Clinical, Medical Devices, Postmarket surveillance

Tags: Leadless Pacemakers

Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance By Zachary Brennan - Published 16 March 2017

Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday.

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

Tags: GlaxoSmithKline, Regeneron, Novartis, Teva, BIO, Celgene, AstraZeneca, clinical trial endpoints

FDA Warns of Increased Risk of Serious Pancreatitis with Allergan’s Viberzi By Zachary Brennan - Published 15 March 2017

Following the death of two patients without a gallbladder on Allergan’s irritable bowel drug Viberzi (eluxadoline), the US Food and Drug Administration (FDA) on Wednesday warned about the increased risk of serious pancreatitis in such patients.

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

Tags: Viberzi, pancreatitis, Viberzi deaths, gallbladder

FDA Warns of Complications With Neurovascular Catheters By Michael Mezher - Published 01 March 2017

The US Food and Drug Administration (FDA) on Wednesday warned healthcare providers of potential harm to patients when neurovascular guide catheters are used to remove blood clots in stroke patients.

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

Tags: Neurovascular Thrombus Retrieval Catheters, Neurovascular Guide Catheters

GAO: FDA's Ability to Monitor Drug Shortages Remains a Concern By Michael Mezher - Published 16 February 2017

The US Food and Drug Administration's (FDA) oversight of medical products remains a high-risk area for the federal government, particularly with regard to the agency's oversight of drug shortages, according to a report from the Government Accountability Office (GAO) released Wednesday.

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

Tags: GAO, Government Accountability Office, Drug Shortages

EMA Touts Growth of Post-Authorisation Study Database By Michael Mezher - Published 13 February 2017

The European Medicines Agency (EMA) on Friday announced it has published more than 1,000 post-authorization studies in a public online database.

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

Tags: Post-Authorisation Studies, PAS, EU PAS Register

PMDA Head Talks Priorities for 'Rational Medicine' By Michael Mezher - Published 10 February 2017

The head of Japan's Pharmaceuticals and Medical Devices Agency (PMDA), Tatsuya Kondo, on Thursday released a paper discussing his vision for a patient-centric, regulatory science-driven and evidence-based system for medicine in Japan.

Categories: News, Japan, MHLW, PMDA, Biologics and biotechnology, Drugs, Medical Devices, Postmarket surveillance

Tags: Tatsuya Kondo, Rational Medicine, Regulatory Science

FDA Details Combination Product Postmarket Safety Reporting Requirements By Michael Mezher - Published 09 February 2017

The US Food and Drug Administration (FDA) is looking to clarify its expectations for combination product manufacturers adjusting to the agency's recently released final rule for postmarket safety reporting.

Categories: News, US, FDA, Combination products, Postmarket surveillance

Tags: Postmarketing Safety Reporting, PMSR, Combination Products, Record Retention

FDA Warns of Risks From Fluid-Filled Stomach Balloons to Treat Obesity By Zachary Brennan - Published 09 February 2017

The US Food and Drug Administration (FDA) on Thursday sent a letter to health care providers noting the receipt of dozens of reports for two different types of adverse events linked to fluid-filled intragastric balloons used to treat obesity. 

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

Tags: fluid-filled intragastric balloons, obesity treatment, obesity, balloon system

GAO: Adverse Event Reporting Limitations Delayed FDA Action on Power Morcellators By Michael Mezher - Published 08 February 2017

The Government Accountability Office (GAO) on Wednesday released the results of its year-and-a-half long investigation into the US Food and Drug Administration's (FDA) handling of laparoscopic power morcellators following reports that the devices spread cancer in patients being treated for uterine fibroids.

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

Tags: Laparoscopic Power Morcellators, Power Morcellators, Government Accountability Office, GAO

Committee Recommends Adding UDIs to Insurance Claims Forms By Michael Mezher - Published 03 February 2017

The group tasked with developing the standards for insurance claims forms on Wednesday recommended including unique device identifiers (UDI) on claims forms.

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

Tags: UDI, Unique Device Identifier, X12, Accredited Standards Committee, Claims Forms

Swissmedic To Prioritize Electronic Adverse Events Reports By Michael Mezher - Published 30 January 2017

Swiss drug regulator Swissmedic on Monday announced it will begin prioritizing the review of electronically submitted adverse drug reaction (ADR) reports in light of a recent influx of such reports.

Categories: News, Europe, Drugs, Postmarket surveillance

Tags: Swissmedic, Adverse Drug Reaction, ADR, ELViS, E2B Gateway

FDA Issues Long-Awaited Biosimilar Interchangeability Guidance By Michael Mezher - Published 17 January 2017

The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability.

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

Tags: Biosimilar, Biosimilar Interchangeability, Draft Guidance, Switching Study

Analysis: Longer Review Times Associated With Fewer Adverse Events for High-Risk Heart Devices By Michael Mezher - Published 13 January 2017

A new analysis finds longer regulatory review times for high-risk cardiovascular medical devices to be associated with fewer adverse event reports, and a lower likelihood of such reports citing serious injury or death.

Categories: News, Europe, US, EC, FDA, Medical Devices, Postmarket surveillance, Submission and registration

Tags: Adverse Event Reports, AER, Safety

FDA, DHS Find Cybersecurity Vulnerabilities in St. Jude Heart Devices By Michael Mezher - Published 11 January 2017

The US Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory on Monday warning of cybersecurity vulnerabilities found in St. Jude Medical's Merlin@home wireless transmitter that could affect the company's line of implantable cardiac devices (ICDs).

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

Tags: Cybersecurity, Medical Device Cybersecurity, St. Jude Medical, MedSec, Muddy Waters Research, Merlin@home Transmitter

CDRH Speeds Release of Device Recall Information By Zachary Brennan - Published 03 January 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday began posting medical device recall information in a searchable database much earlier than the agency ever has before.

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

Tags: device recalls, FDA recalls, recall coordinators

FDA Issues Long-Awaited Final Rule on Combo Product Postmarket Safety By Zachary Brennan - Published 19 December 2016

More than the seven years after it was first proposed, the US Food and Drug Administration (FDA) on Monday finalized new postmarket safety reporting requirements for combination products.

Categories: News, US, FDA, Combination products, Postmarket surveillance

Tags: combo product rule, FDA postmarket regulations, postmarket safety of combination products