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Filtering on: "topics compliance"

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US Supreme Court to Review Biosimilar ‘Patent Dance’ By Zachary Brennan - Published 13 January 2017

The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Due Diligence, Government affairs

Tags: SCOTUS, John Roberts, biosimilar patent dance, biosimilars and SCOTUS

Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance By Zachary Brennan - Published 13 January 2017

The US Food and Drug Administration (FDA) on Friday continued its flurry of draft guidance for generic drug companies (releasing its third in the last two days), this one for potential applicants planning to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug and a delivery device.

Categories: News, US, FDA, Clinical, Combination products, Compliance, Government affairs

Tags: Mylan, EpiPen, generic drug-device combination products, FDA draft guidance

Non-Proprietary Naming of Biologics and Biosimilars: FDA Finalizes Guidance By Zachary Brennan - Published 12 January 2017

In a departure from the way the WHO and Europe name biologics, the US Food and Drug Administration (FDA) on Thursday finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Labeling, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: biosimilar names, non-proprietary biologic naming, biologic names, FDA guidance

Danish Regulator Suspends Parallel Importer's GMP Certificate By Michael Mezher - Published 06 January 2017

The Danish Medicines Agency has suspended Danish parallel importer Europharma DK's manufacturing authorisation and good manufacturing practice (GMP) certificate over "serious breaches of compliance" uncovered during an inspection of the company's Esbjerg, Denmark site last month.

Categories: News, Europe, Compliance, Distribution, Drugs, Packaging

Tags: Danish Medicines Agency, Europharma DK

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

Submitting Manufacturing Establishment Info Electronically: FDA Offers Draft Guidance By Zachary Brennan - Published 03 January 2017

Pharmaceutical manufacturers take note: The days of non-electronic submissions of establishment information are coming to an end, possibly as soon as 2019.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Compliance, Drugs, Manufacturing

Tags: pharmaceutical manufacturing, draft guidance, manufacturing information

FDA Warns Wockhardt for Destroying CGMP Documents, Other Violations By Zachary Brennan - Published 03 January 2017

The beleaguered Indian drug manufacturer Wockhardt is in trouble again with the US Food and Drug Administration (FDA), this time for destroying current good manufacturing practice (CGMP) documents, among a list of other major violations.

Categories: News, Asia, FDA, Active pharmaceutical ingredients, Compliance, Crisis management, Drugs, Due Diligence, Manufacturing

Tags: warning letter, Wockhardt, CGMP

2016 in Review for Drug and Device Regulations: An 11th Hour Reckoning By Zachary Brennan - Published 20 December 2016

Turn back the clock to late October and those first 10 months of 2016 look like a relatively commonplace year for the pharma and medical device industries and their US regulatory counterpart, the US Food and Drug Administration (FDA) (on the EU side, Brexit was already causing headaches for the European Medicines Agency (EMA) as early as June).

Categories: News, Europe, US, EC, EMA, FDA, MHRA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Labeling, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical regulations, year in review, Cures, Trump

FDA to Publicly Disclose ‘Emerging Signals’ Info for Medical Devices By Zachary Brennan - Published 13 December 2016

The public will soon see more prompt notifications on medical device risks and potential risks thanks to guidance finalized Tuesday by the US Food and Drug Administration (FDA).

Categories: News, US, CDRH, Compliance, Crisis management, Ethics, Medical Devices, Regulatory intelligence, Submission and registration

Tags: emerging signals, medical device risks, medical device data, FDA publishing medical device data

FDA, NIH Unveil Initial Framework for Biomarker Qualification By Zachary Brennan - Published 12 December 2016

Officials from the US Food and Drug Administration (FDA), the Foundation for the National Institutes of Health (NIH) and other stakeholders, including experts from Genentech, Merck, Pfizer and Takeda, have released a framework for the proposed evidentiary criteria to support the regulatory acceptance of biomarker use in drug development programs.

Categories: News, US, FDA, Clinical, Compliance, Drugs, Regulatory intelligence, Regulatory strategy

Tags: biomarker, biomarker qualification, 21st Century Cures, Woodcock, evidentiary criteria

Quality and Compliance, Regulatory Research, Policy Issues and a Preview of December By Gloria Hall - Published 02 December 2016

The following is a summary of feature articles posted throughout November with links and a preview of what's to come in December.

Categories: Features, Compliance, Quality

Tags: Regulatory Focus, Feature Articles, Feature Summary

How to Mitigate Cross-Contamination During Colonoscopies, Final FDA Guidance Explains By Zachary Brennan - Published 29 November 2016

During a colonoscopy or esophagogastroduodenoscopy (EGD), clinicians often use an irrigation system but typically do not clean and sterilize all components of the system after each procedure, so the US Food and Drug Administration (FDA) on Tuesday issued guidance highlighting the risks of cross-contamination posed by specific practices and types of irrigation valves and accessories.

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

Tags: colonoscopy, cross-contamination of medical devices, medical device safety, device irrigation systems

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

FDA Sees Better Industry Compliance With Postmarket Requirements By Michael Mezher - Published 28 November 2016

A new report from the US Food and Drug Administration (FDA) reveals improvements made by industry in complying with postmarketing requirements (PMRs) and postmarketing commitments (PMCs) for Fiscal Year (FY) 2015.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs

Tags: Postmarketing commitments, Postmarketing requirements

FDA Warns Wockhardt Subsidiary Over Aseptic Production Issues By Michael Mezher - Published 22 November 2016

The US Food and Drug Administration (FDA) sent a warning letter to Wockhardt Limited founder Habil Khorakiwala last week over good manufacturing practice (GMP) violations at the company's CP Pharmaceuticals subsidiary in Wrexham, UK.

Categories: News, Europe, US, FDA, Compliance, Drugs, Manufacturing

Tags: Aseptic Processing, Warning Letter

FDA Finalizes Contract Manufacturer Quality Arrangement Guidance From 2013 By Zachary Brennan - Published 22 November 2016

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on contract manufacturer quality agreements.

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Government affairs, Manufacturing

Tags: contract manufacturers, CMOs, FDA guidance

EMA Offers New Guidance on Type II Variations and MA Extensions of Orphan Drugs By Zachary Brennan - Published 21 November 2016

The European Medicines Agency (EMA) has updated its post-authorization guidance on how extensions of marketing authorizations and type II variations may impact orphan-designated medicines.

Categories: News, Europe, EC, EMA, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: EMA, type II variation, orphan medicines, COMP

Why Respond to an FDA 483 in a Timely Manner By Alan Minsk, Kelley Nduom - Published 21 November 2016

We reviewed some warning letters issued by the US Food and Drug Administration (FDA) this year that reminded us of the 1981 hit song by Styx, "Too Much Time on My Hands." Two companies had received a FDA 483 List of Observations following an inspection.1, 2 The companies accordingly responded to the agency within 15 business days; however, they also provided subsequent substantive responses to the FDA 483 outside of the 15-day window. In the warning letters, FDA acknowledged the companies' initial responses, but noted the subsequent responses were untimely and not reviewed by the agency as it considered potential next enforcement steps.

Categories: Features, US, FDA, Communication, Compliance, Regulatory strategy

Sanofi Halts Production of Bladder Cancer Drug as Others Fail to Win FDA Approval By Zachary Brennan - Published 18 November 2016

Sanofi Pasteur said it’s discontinuing the manufacture of TheraCys, an important bladder cancer drug, and shortages are expected, while the US Food and Drug Administration (FDA) on Friday released draft guidance to help develop new treatments for BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC).

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Government affairs, Quality, Regulatory strategy

Tags: bladder cancer, NMIBC, Sanofi, drug shortage

EU’s Pediatric Regulation: European Commission Seeks Feedback for New Report By Zachary Brennan - Published 15 November 2016

The European Commission (EC) on Tuesday launched a public consultation to obtain feedback for its second report on the Pediatric Regulation, ten years after its implementation.

Categories: News, Europe, EC, EMA, MHRA, Clinical, Compliance, Due Diligence, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Paediatric Regulation, PIPs, PIP cost to pharmaceutical industry

What the Incoming Trump Administration may Mean for FDA, Biopharma and Device Companies By Zachary Brennan - Published 10 November 2016

As pharmaceutical and biotech company stocks saw a quick rise in share prices yesterday, investors seem to believe the incoming Donald Trump administration and the avoidance of a California ballot measure on drug pricing will have a positive impact on the sector as a whole, at least financially.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Medical Devices, Quality

Tags: Donald Trump and HHS, Trump and FDA, drug regulations and Trump, Mike Pence

Health Canada Issues New Medical Device Recall Guide By Michael Mezher - Published 04 November 2016

Health Canada on Thursday issued a new guide on medical device recalls detailing sponsors' responsibilities under the country's Medical Devices Regulations (MDR), replacing the agency's 2011 guidance.

Categories: News, Canada, Health Canada, Compliance, Distribution, Medical Devices, Product withdrawl and retirement

Tags: Medical Device Recalls

You Only Get One Chance to Make a First Impression - Do It Right The First Time (DIRTFT) By Michael Chellson - Published 02 November 2016

This article speaks to the unique opportunity "start-up" organizations have to create and implement robust compliance and quality system paradigms and systems "right the first time" to accommodate growth and prevent later compliance issues.

Categories: News, US, FDA, Compliance, Medical Devices

Regulatory Misconduct: FDA Launches Website for Allegations Against Device Manufacturers By Zachary Brennan - Published 24 October 2016

A little more than a week after a scathing report in the Minneapolis Star-Tribune revealed the US Food and Drug Administration (FDA) has accepted late adverse event reports from device companies for hundreds of thousands of incidents, and the agency on Monday launched a new website for regulatory misconduct allegations.

Categories: News, US, CDRH, Compliance, Crisis management, Ethics, Medical Devices

Tags: regulatory misconduct, medical device companies and adverse events, misconduct and FDA

EMA Sets Deadlines for 2016 Type I Variations By Zachary Brennan - Published 24 October 2016

The European Medicines Agency (EMA) on Monday said that marketing authorization holders (MAHs) need to submit any minor changes to drug marketing authorizations, also known as Type IAIN and Type IA variations, for 2016 by 30 November.

Categories: News, Europe, EMA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs, Project management

Tags: Type I variations, EMA deadlines