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Filtering on: "topics postmarket surveillance"

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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

New FDA Warnings for Anesthetic Use in Young Children and Pregnant Women By Zachary Brennan - Published 14 December 2016

The U.S. Food and Drug Administration (FDA) on Wednesday warned that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than three years or in pregnant women during their third trimester may affect the development of children’s brains.

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

Tags: anesthesia, sedation, toddlers and surgery, pregnant women and sedation

FDA Finalizes Drug Supply Chain Guidance, Seeks Comment on New Section By Zachary Brennan - Published 08 December 2016

The US Food and Drug Administration (FDA) on Thursday released final guidance on the implementation of the Drug Supply Chain Security Act (DSCSA), though it’s also seeking comment on a new section describing when manufacturers should notify FDA of a high risk that a product is illegitimate.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Crisis management, Drugs, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: DSCSA, track and trace, supply chain pharmaceuticals, FDA guidance

FDA Warns Specialty Pharma Company Over Adverse Event Reporting By Michael Mezher - Published 30 November 2016

The US Food and Drug Administration (FDA) sent a warning letter to Langhorne, Pennsylvania-based STI Pharma LLC for failing to meet the agency's requirements for adverse event reporting.

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

Tags: STI Pharma LLC, Postmarketing Adverse Drug Experience, PADE

Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA By Zachary Brennan - Published 28 November 2016

Lingering for more than two years, the revamped 21st Century Cures bill, unveiled in late November, has now been approved by the House and Senate and President Barack Obama has said he will sign it.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Compliance, Drugs, Government affairs, Human cell and tissue, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: 21st Century Cures, drug regulations, Congress and medical innovation, NIH, FDA innovation, Cures Now

CMS Updates Drug Pricing Dashboard, Calls for Affordable and Accessible Pharmaceuticals By Zachary Brennan - Published 14 November 2016

As the rising prices of pharmaceuticals continue to hurt Americans' pockets, the US Centers for Medicare & Medicaid Services (CMS) are using transparency to highlight some of the steepest price spikes that are costing Medicare and Medicaid the most.

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

Tags: CMS, drug spending dashboard, pharmaceutical prices

Medical Device Manufacturer Pleads Guilty to Misbranding and Agrees to Pay $36M By Zachary Brennan - Published 11 November 2016

Pennsylvania-based medical device manufacturer Biocompatibles Inc., a BTG subsidiary, pleaded guilty earlier this week to misbranding its embolic device used to treat liver cancer, among other diseases, and will pay more than $36 million due its illegal conduct, the Justice Department (DOJ) said. 

Categories: News, US, DOJ, FDA, Advertising and Promotion, Crisis management, Government affairs, Medical Devices, Postmarket surveillance, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: Biocompatibles, misbranded medical devices, drug delivery, chemotherapy, LC Bead, BTG

FDA Finalizes Guidance on Boxed Warning, Patient Decision Checklist for Essure Devices By Michael Mezher - Published 31 October 2016

The US Food and Drug Administration (FDA) on Friday finalized its guidance requiring a boxed warning and patient decision checklist for Bayer's permanent implantable birth control device Essure.

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

Tags: Essure, Boxed Warning, Patient Decision Checklist

FDA Report Offers Complicated Picture of Industry Compliance With Postmarket Requirements By Zachary Brennan - Published 28 October 2016

The majority of ongoing postmarketing requirements (PMRs) and postmarketing commitments (PMCs) from Fiscal Years 2013 and 2014 were on schedule, but a large number of companies are still struggling to meet some of these regulatory requirements on time, the US Food and Drug Administration (FDA) said in a new report issued Friday.

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

Tags: postmarketing requirements, postmarketing commitments, PMR, PMC, clinical trials after marketing

GAO: FDA Needs to Improve Cybersecurity Measures With Non-Public Info By Zachary Brennan - Published 29 September 2016

Despite recent steps to improve cybersecurity, the US Government Accountability Office (GAO) said Thursday that the US Food and Drug Administration (FDA) needs to better protect industry and public health data.

Categories: News, US, FDA, Business and Leadership, Postmarket surveillance, Project management

Tags: IT security, non-public data and FDA

FDA May Push Back Release of Biosimilar Interchangeability Draft Guidance By Zachary Brennan - Published 22 September 2016

Although the Food and Drug Administration (FDA) has continued to say that draft guidance on how an interchangeable biosimilar will be defined should come out by the end of 2016, the user fee reauthorization commitment letter released this week says the draft will publish sometime before 31 December 2017.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: biosimilar, interchangeability, BsUFA

FDA Finalizes New Regulations for Drugmakers a Decade After First Proposal By Zachary Brennan - Published 30 August 2016

After a decade of consideration, the US Food and Drug Administration (FDA) on Tuesday finalized new regulations governing drug establishment registration and drug listing for foreign and domestic firms, though the agency stopped short of finalizing several provisions that commenters took issue with.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Business and Leadership, Crisis management, Drugs, Government affairs, Labeling, Packaging, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: NDCs, drug establishment registration, FDA drug lists, FDA rules, drug regulations

Illinois Attorney General Sues Fentanyl Drugmaker for Deceptive Off-Label Marketing By Zachary Brennan - Published 25 August 2016

Illinois Attorney General Lisa Madigan on Thursday filed a lawsuit against Insys Therapeutics for deceptively marketing and selling its opioid Subsys (fentanyl), approved exclusively for the treatment of cancer pain, to physicians treating non-cancer patients for off-label uses like back and neck pain.

Categories: News, US, FDA, Drugs, Government affairs, Postmarket surveillance, Product withdrawl and retirement

Tags: opioid, off-label marketing, pharmaceutical lawsuits, Insys Therapeutics

Approval of Anthrax Vaccine Under FDA’s Animal Rule is a Step Forward, Researchers Argue By Zachary Brennan - Published 25 August 2016

Although the US Food and Drug Administration’s (FDA) 2015 approval of the vaccine BioThrax for postexposure prophylaxis (PEP) for inhalational anthrax wasn’t the first approval under the rarely used Animal Rule, researchers in Nature explained on Thursday why it is a “significant step forward” in the approval of new vaccines and other medical countermeasures under the pathway.

Categories: News, Canada, Europe, US, FDA, Biologics and biotechnology, Clinical, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: Animal Rule, Nature, Accelerated Approval, Ebola, Anthrax, medical countermeasures

FDA Warns of Serious Risks for Syringe Pumps at Low Infusion Rates By Michael Mezher - Published 25 August 2016

The US Food and Drug Administration (FDA) on Thursday issued a warning to healthcare providers over serious adverse events tied to programmable syringe pumps when set to deliver drugs at lower volumes, especially for infants and critically ill patients.

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

Tags: Syringe pumps, Safety communication

Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program By Zachary Brennan - Published 23 August 2016

The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017.

Categories: News, US, CDRH, Government affairs, Medical Devices, Postmarket surveillance, Preclinical, Project management, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: MDUFA, medical device user fee agreement, AdvaMed, MITA, CLIA, LDTs

EMA Releases List of Medical Events for Pharmacovigilance Monitoring By Michael Mezher - Published 19 August 2016

The European Medicines Agency (EMA) has released a list of standardized terms describing medical events it says will be used by the agency and other European regulators to identify suspected adverse events.

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

Tags: Pharmacovigilance, EudraVigilance, Designated Medical Events, Important Medical Events

European Regulatory Roundup: Clinical Trial Delays Prompt EMA to Consider Revising Guidance (18 August 2016) By Nick Paul Taylor - Published 18 August 2016

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

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

Tags: European Regulatory Roundup, clinical trial guidance, EFPIA, Novo Nordisk, HTA

FDA: Custom Ultrasonics' Endoscope Reprocessors Still Unsafe By Michael Mezher - Published 17 August 2016

The US Food and Drug Administration (FDA) on Wednesday said it is maintaining its recommendation against the use of Custom Ultrasonics' System 83 Plus automated endoscope reprocessors (AERs) to clean duodenoscopes after finding the reprocessors were not adequately validated last November.

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

Tags: Endoscope, Duodenoscopes, Custom Ultrasonics', Superbug Outbreak, CRE, Recall

UK’s MHRA Cautions Diabetics on Roche’s Leaky Insulin Cartridges By Zachary Brennan - Published 16 August 2016

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that patients with diabetes using Roche’s Accu-Chek Insight insulin pump should be careful when inserting pre-filled insulin cartridges as Roche has reported an increasing number of instances when patients experienced leaking insulin cartridges.

Categories: News, Europe, MHRA, Crisis management, Drugs, Government affairs, Medical Devices, Postmarket surveillance, Quality

Tags: Roche, insulin pumps, leaking insulin pumps, patients with diabetes, MHRA alerts

EMA Adopts New Biologic, Biosimilar Pharmacovigilance Guidance By Michael Mezher - Published 15 August 2016

The European Medicines Agency (EMA) on Monday announced new recommendations for monitoring the safety of biologics and biosimilars. The guidance will take effect on 16 August 2016.

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

Tags: Pharmacovigilance

Chinese and Indian Firms Warned and Banned by US FDA and German Competent Authority By Zachary Brennan - Published 12 August 2016

A lack of quality assurance (QA) oversight, a refusal of an inspection by the US Food and Drug Administration (FDA) and a failure to commit to any corrective actions regarding current good manufacturing practice (CGMP) violations observed on an FDA inspection landed a Chinese company an FDA warning letter, and a statement of non-compliance and a ban for two Indian companies recently.

Categories: News, Asia, Europe, US, EC, EMA, FDA, Active pharmaceutical ingredients, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Product withdrawl and retirement, Quality

Tags: China drug manufacturing, Indian APIs, statement of noncompliance, warning letter