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Filtering on: "topics ethics"

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Experts Tell Senate Committee Current Gene Editing Regulations are Appropriate By Michael Mezher - Published 14 November 2017

At a Senate Health, Education, Labor and Pensions (HELP) hearing in Washington, D.C. on Tuesday, experts explained that the current regulatory framework for gene editing in the US is appropriate and cautioned that an overly strict approach could drive research to other countries.

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

Tags: Gene Editing, Gene Therapy, CRISPR, CRISPR-Cas9, Editas

FDA Halts Monkey Study on Nicotine Dosing By Zachary Brennan - Published 06 October 2017

FDA last month halted monkey research on nicotine dosing following concerns, including those raised in a letter from primatologist Jane Goodall.

Categories: News, US, FDA, Ethics

Tags: nicotine research, NCTR, FDA research

FDA: 30 Percent of Drugs Used in Expanded Access Programs are Later Approved By Michael Mezher - Published 20 September 2017

A new paper by a team of US Food and Drug Administration (FDA) officials finds that only about 30%of drugs requested for expanded access go on to be approved by the agency.

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

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

Patients Not Always Informed of Study's Purpose in Noninferiority Trials By Michael Mezher - Published 23 August 2017

A study published in JAMA Internal Medicine this week finds that patients participating in noninferiority trials for antibiotics are not always accurately informed of the purpose of the study, based on an analysis of informed consent forms.

Categories: News, EMA, FDA, Clinical, Drugs, Ethics

Tags: Noninferiority, Superiority, Antibiotics, Clinical Trials, Informed Consent

Studies Raise Questions on Trial Designs for New Drugs, Devices Sped to Market By Zachary Brennan - Published 15 August 2017

Two new articles and an accompanying editorial from former US Food and Drug Administration (FDA) commissioner Robert Califf published Tuesday in JAMA raise questions about the risks of speeding new drugs and medical devices to market without enough preliminary evidence that they are effective.

Categories: News, US, FDA, Drugs, Ethics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: surrogate measures, accelerated approval, high-risk devices, Rob Califf

FDA Issues Guidance on Informed Consent Waivers for Minimal Risk Studies By Michael Mezher - Published 24 July 2017

The US Food and Drug Administration (FDA) on Monday issued a final guidance detailing the circumstances in which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants.

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

Tags: Informed Consent, Minimal Risk, 21st Century Cures

Researchers Find Most Expert Speakers at FDA ODAC Meetings Receive Sizable Industry Payments By Zachary Brennan - Published 05 July 2017

Experts speaking on behalf of a pharmaceutical company at US Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) meetings often receive sizable sums, raising questions about the relationships between the companies and the experts ahead of three ODAC meetings next week.

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

Tags: ODAC, Oncology Drug Advisory Committee, FDA advisory committees

New Texas Law on Stem Cell Treatments: Showdown With FDA Coming? By Zachary Brennan - Published 28 June 2017

With a new Texas law now in the books to allow companies to sell unproven stem cell treatments without US Food and Drug Administration (FDA) approval, some experts wonder when FDA will step in to shut down companies and clinics exposing people to unapproved medical products.

Categories: News, US, FDA, Clinical, Ethics, Government affairs, Human cell and tissue

Tags: Texas stem cell treatments, stem cells

ABPI Extends Astellas UK Suspension for 12 More Months By Zachary Brennan - Published 28 June 2017

The Association of the British Pharmaceutical Industry (ABPI) has announced that Astellas UK’s suspension as a member company has been extended for 12 more months as recent cases have shown a "lamentable lack of concern for patient safety."

Categories: News, Europe, Compliance, Crisis management, Ethics

Tags: ABPI, Astellas, prescribing information

US Supreme Court to Consider Biosimilar Patent Process Next Week By Zachary Brennan - Published 20 April 2017

The highest court in the US next Wednesday will take up a fight over the so-called biosimilar "patent dance" and whether biosimilar companies have to notify reference product sponsors of the impending marketing of a new product, likely leading to a decision with ramifications for all subsequent biosimilars approved by the US Food and Drug Administration (FDA).

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

Tags: biosimilars, Amgen, Sandoz, patents

FDA Hedges: A Proposal to Better Share R&D Risks By Zachary Brennan - Published 19 April 2017

The probability that an investigational drug will succeed in all three phases of clinical trials and win US Food and Drug Administration (FDA) approval is very low. So low, in fact, that a group of economists have written a new paper calling for a system whereby developers could hedge their research and development (R&D) risks by buying options that would pay companies a pre-specified amount in the event that a treatment fails a given phase of the FDA approval process.

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

Tags: R&D risk, pharmaceutical risks, FDA hedges

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

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

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

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