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Filtering on: "topics ethics"

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FDA Approved Nearly All Expanded Access Requests in FY2016 By Michael Mezher - Published 20 March 2017

The US Food and Drug Administration (FDA) granted more than 99% of requests for patients to access unapproved drugs and biologics in fiscal year 2016, according to data released last week.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Ethics

Tags: Expanded Access, Compassionate Use, Right-To-Try

Celgene, Takeda and Others Found in Breach of UK’s Pharma Code of Practice By Zachary Brennan - Published 14 March 2017

When is it OK for a pharmaceutical company to fail to quality check bags stored in a basement for three years before supplying them to pharmacies to use when dispensing the chemotherapy Navelbine (vinorelbine) to patients? Apparently never, according to Tuesday’s rundown of companies breaching the Association of British Pharmaceutical Industry’s (APBI) Code of Practice.

Categories: News, Europe, MHRA, Biologics and biotechnology, Compliance, Crisis management, Drugs, Ethics

Tags: Celgene, Takeda, Pierre Fabre, PMCPA, ABPI

Canada to Require Drugmakers to Publicly Disclose Drug Shortages By Zachary Brennan - Published 13 March 2017

Beginning on Tuesday, 14 March, amendments to Canada’s Food and Drug Regulations will come into force making it mandatory for drug authorization holders to publicly report drug shortages and discontinuations to two websites, DrugShortagesCanada.ca and PenuriesDeMedicamentsCanada.ca.

Categories: News, Canada, Health Canada, Business and Leadership, Drugs, Ethics, Government affairs

Tags: drug shortages, Food and Drug Regulations

Senators Ask GAO to Probe Orphan Drug Act as Questions Pile up Over Marathon’s Pricey Steroid By Zachary Brennan - Published 06 March 2017

As US Duchenne Muscular Dystrophy (DMD) patients may be hit with a 50 to 70 times more expensive price for a steroid they have been importing from the EU and Canada for about $1,000 per year, eight Democratic senators sent a letter on Friday to Marathon Pharmaceuticals questioning the orphan drug Emflaza’s (deflazacort) $89,000 list price, while three Republican senators on Friday also asked the US Government Accountability Office (GAO) to look into orphan drugs in general.

Categories: News, US, Drugs, Ethics, Government affairs

Tags: Emflaza, deflazacort, Marathon Pharmaceuticals, Warren, Booker

Public Citizen Warns 'Right to Try' Gives Patients False Hope By Michael Mezher - Published 06 March 2017

Advocacy nonprofit Public Citizen is calling on members of Congress to oppose several "right to try" bills, warning that the bills would undermine the US Food and Drug Administration (FDA) and provide false hope to patients.

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

Tags: Right to Try, Public Citizen

Maryland Goes a Step Further to Rein in Drug Price Spikes By Zachary Brennan - Published 27 February 2017

A Maryland bill to shine more light on prescription drug prices takes the standard for state transparency efforts a step further by not only requiring pharmaceutical companies to offer a peek into their innerworkings but requires annual reports to be audited by third parties.

Categories: News, US, Biologics and biotechnology, Drugs, Ethics, Government affairs

Tags: drug price transparency, Maryland drug price bill, drug transparency

EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research By Zachary Brennan - Published 17 February 2017

The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating the consensus that, when alternatives do not exist, appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for the safety assessment of pharmaceuticals.

Categories: News, Europe, EC, Compliance, Crisis management, Drugs, Ethics, Government affairs, Human cell and tissue, Medical Devices, Preclinical

Tags: animal research, drug safety testing, non-human primates, European Commission Opinion

Trump’s ‘Two Out, One In’ Regulatory Policy May Apply to Some FDA Guidance By Zachary Brennan - Published 06 February 2017

The Office of Management and Budget (OMB) late last week offered guidance to federal agencies, including the US Food and Drug Administration (FDA), trying to figure out how the new “two out, one in” executive order (EO) will impact their issuance of guidance and rulemakings moving forward.

Categories: Compliance, Crisis management, Due Diligence, Ethics, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: "two out, one in," Trump regulatory policy, FDA regulations

Trump Signals Support for 'Right-to-Try' Movement By Michael Mezher - Published 02 February 2017

In a meeting with pharmaceutical industry executives on Tuesday, President Donald Trump expressed his concern that the US Food and Drug Administration (FDA) is standing in the way of terminally ill patients accessing unapproved drugs as treatments of last resort.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Ethics, Government affairs

Tags: Trump, Right-to-Try

Aging Revisited: an Amazing Continuous Process By Max Sherman - Published 24 January 2017

This article will briefly discuss the definition of aging, what it means to age, the process itself, why we age and anti-aging methods designed to increase longevity. Active research has indicated a number of medications have increased the life span in mice and other laboratory animals. Duplicating the results in human patients could make anti-aging medications the next category of truly miracle drugs.

Categories: Features, Biologics and biotechnology, Drugs, Ethics

WTO Makes Permanent a Way to Help Poor Countries Gain Access to Generics via Compulsory Licenses By Zachary Brennan - Published 23 January 2017

The World Trade Organization (WTO) on Monday officially amended its Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement to allow developing countries facing public health problems and lacking the capacity to produce generic drugs the ability to obtain such medicines from third country producers under "compulsory licensing" arrangements. 

Categories: News, Asia, Canada, Europe, US, Generic drugs, Ethics, Regulatory intelligence, Regulatory strategy

Tags: WTO, TRIPS, compulsory licenses, generic drugs

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

Ethical Guidelines for Human Research Revised By Michael Mezher - Published 06 December 2016

The Council for International Organizations of Medical Sciences (CIOMS) last week finalized the latest revision to its ethical guidelines for health research involving human participants.

Categories: News, Clinical, Ethics

Tags: Council for International Organizations of Medical Sciences, CIOMS, Medical Ethics

FDA Begins Consultation on Update to ICH Pediatric Clinical Trials Guidance By Michael Mezher - Published 21 November 2016

The US Food and Drug Administration (FDA) on Monday launched a three-month public consultation on an addendum to the International Council for Harmonisation's (ICH) guidance on pediatric clinical trials.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Clinical, Drugs, Ethics, Regulatory strategy

Tags: Pediatric drug development, ICH E11

European Regulatory Roundup: Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System (10 November 2016) By Nick Paul Taylor - Published 10 November 2016

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

Categories: News, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Ethics, Government affairs, Medical Devices

Tags: Brexit, Big Data, regulatory science, social media, adverse event reporting

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

FDA Warns Brazilian OTC Drug Manufacturer By Zachary Brennan - Published 04 October 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Brazil’s Mappel Industria de Embalagens last month for four violations, though the over-the-counter (OTC) drug manufacturer told FDA that it did not realize the products were regulated by FDA.

Categories: News, Latin America and Caribbean, US, FDA, Compliance, Crisis management, Over the counter drugs, Ethics, Manufacturing

Tags: warning letter, Brazil OTC drugs, OTC drug regulations

ICER on PD-1 Immunotherapies to Treat Lung Cancer: Lower the Prices By Zachary Brennan - Published 03 October 2016

In a new report on non-small cell lung cancer (NSCLC) treatments, the Institute for Clinical and Economic Review (ICER) found that for PD-1 immunotherapies, which are also often used to treat melanoma, the cost may be too high in terms of lengthening progression-free and overall survival.

Categories: News, US, Biologics and biotechnology, Due Diligence, Ethics, Regulatory strategy, Reimbursement, Research and development

Tags: NSCLC, lung cancer, ICER

European Regulatory Roundup: AstraZeneca Pulls Cancer Drug After Disagreement With EMA (29 September 2016) By Nick Paul Taylor - Published 29 September 2016

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

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Crisis management, Drugs, Ethics

Tags: AstraZeneca, Alexion, Strensiq, PCWP

Former Regulatory Affairs Director Charged With Insider Trading By Zachary Brennan - Published 29 September 2016

The US Securities and Exchange Commission (SEC) on Thursday charged Robert Gadimian, former senior director of regulatory affairs for Puma Biotechnology, with making more than $1.1 million thanks to non-public information linked to the company’s breast cancer treatment.

Categories: News, US, FDA, Clinical, Crisis management, Drugs, Ethics

Tags: regulatory affairs, insider trading, Puma Biotechnology

FDA and the Public Interest: The Problem With Drug Reviewers Moving to Industry By Michael Mezher - Published 28 September 2016

A new analysis published in The BMJ finds that more than a quarter of hematology and oncology drug reviewers at the US Food and Drug Administration (FDA) left the agency to work or consult for the biopharmaceutical industry between 2001 and 2010.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Ethics, Government affairs

Tags: Conflict of Interest

FDA Issues Untitled Letter for Website Promotion of an Opioid 10 Days Before PDUFA Date By Zachary Brennan - Published 14 September 2016

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is calling on Durect and Pain Therapeutics to pull promotional materials on their websites for their unapproved Remoxy (oxycodone) extended-release capsules as the websites incorrectly suggest that the investigational new drug is safe and effective.

Categories: News, US, FDA, Clinical, Ethics, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: opioid, Durect, Pain Therapeutics, Pfizer, abuse deterrant opioids

FDA Form 483: Theranos Initiated Trials Without IRB Approval By Zachary Brennan - Published 09 September 2016

The US Food and Drug Administration (FDA) on Friday released a Form 483 issued 18 August to blood testing startup Theranos, citing the company for allowing patients to consent to sample collection in two Zika-related trials without approval of an institutional review board (IRB).

Categories: News, US, FDA, Ethics, Government affairs, In vitro diagnostics, Medical Devices

Tags: Theranos, Elizabeth Holmes, Zika, Form 483

Antibacterial Wash Companies Have One Year to Remove 19 Banned Ingredients, FDA Final Rule Says By Zachary Brennan - Published 02 September 2016

The US Food and Drug Administration (FDA) on Friday published a final rule calling on antibacterial wash manufacturers to eliminate 19 ingredients from their products within one year because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.   

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Due Diligence, Ethics, Government affairs

Tags: antibacterial hand wash, hand washes, antibacterial soap

FDA Begins Process of Overhauling Off-Label Communications Regulations By Zachary Brennan - Published 31 August 2016

The US Food and Drug Administration (FDA) on Wednesday announced a new two-day public meeting to address a comprehensive review of its regulations and policies governing firms’ off-label communications on unapproved uses of approved drugs and medical devices.

Categories: News, US, FDA, FTC, Biologics and biotechnology, Business and Leadership, Compliance, Drugs, Ethics, Government affairs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: pharmaceutical off-label communications, Amarin, drug company free speech