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Filtering on: "topics postmarket surveillance"

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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

Petition to FDA Seeks to Modify Trial Regulations Following Deaths By Zachary Brennan - Published 18 May 2017

A petition submitted to the US Food and Drug Administration (FDA) in 2016 has been updated recently, as it seeks to reform FDA requirements for investigational new drug (IND) applications, investigational device exemptions (IDEs) and new drug applications (NDAs).

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

Tags: citizen petition, FDA petition, clinical trial regulations

Biopharma Companies Take Issue With FDA's Draft Biosimilar Interchangeability Guidance By Zachary Brennan - Published 18 May 2017

Ahead of Friday's deadline for comments, a number of biopharmaceutical companies are seeking further clarification from the US Food and Drug Administration (FDA) on various aspects of the draft biosimilar interchangeability guidance.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Labeling, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development

Tags: biosimilars, interchangeability, FDA draft guidance, biosimilar guidance

FDA Adds Boxed Warning to Janssen's Type 2 Diabetes Drug Label By Zachary Brennan - Published 16 May 2017

Based on new data from two large clinical trials, the US Food and Drug Administration (FDA) on Tuesday concluded that Janssen’s type 2 diabetes medicine canagliflozin (brand names include Invokana, Invokamet and Invokamet XR) causes an increased risk of leg and foot amputations.

Categories: News, Europe, US, EMA, FDA, MHRA, Clinical, Crisis management, Drugs, Postmarket surveillance

Tags: Janssen, SGLT2 inhibitors, FDA warning

FDA Drug Approvals on Limited Evidence: Follow-Ups Lacking, Study Finds By Zachary Brennan - Published 08 May 2017

For drugs approved by the US Food and Drug Administration (FDA) based on limited evidence, a recent study published in the British Medical Journal found “noticeable variability” in the degree to which novel drugs were studied in the postmarket period.

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

Tags: surrogate markers, clinical endpoints, postapproval studies

UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers By Zachary Brennan - Published 01 May 2017

No one knows what UK pharmacovigilance will look like after the UK leaves the EU, and that uncertainty puts the many Qualified Persons Responsible for Pharmacovigilance (QPPV) residing in the UK in a precarious position.

Categories: News, Europe, EC, EMA, MHRA, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: Brexit, pharmacovigilance, Ian Hudson

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

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

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

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 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

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

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