Search Results for opioids

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Report Calls on FDA to Adopt New Standard for Reviewing Opioids By Michael Mezher - Published 14 July 2017

The National Academies of Sciences, Engineering and Medicine (NASEM) issued a report Thursday calling on the US Food and Drug Administration (FDA) to change its approach to reviewing opioids in light of the ongoing opioid epidemic.

Categories: News, US, FDA, Clinical, Drugs, Postmarket surveillance, Submission and registration

Tags: Opioids, Opioid Epidemic

Endo Pulls Opioid From US Market at FDA's Request By Zachary Brennan - Published 06 July 2017

Endo International announced Thursday that it will comply with the US Food and Drug Administration’s (FDA) request remove its opioid Opana ER (oxymorphone hydrochloride extended release) from the US market.

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Product withdrawl and retirement

Tags: Endo, Opana ER, opioids, opioid crisis

FDA to Take Closer Look at Abuse-Deterrent Opioids By Michael Mezher - Published 13 June 2017

The US Food and Drug Administration (FDA) on Tuesday announced its next move in addressing the ongoing opioid abuse epidemic will be to take a closer look at the data supporting abuse-deterrent labeling for opioids.

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

Tags: Opioids, Abuse-Deterrent Opioids

Gottlieb Establishes FDA Committee to Confront Opioid Crisis By Zachary Brennan - Published 23 May 2017

Newly-confirmed US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday began to address what he deems to be his "highest initial priority," which is to "reduce the scope of the epidemic of opioid addiction."

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

Tags: opioids, Scott Gottlieb, Opioid Policy Steering Committee

Gottlieb to FDA Staff: Immediate Challenge is Opioid Abuse By Zachary Brennan - Published 16 May 2017

Scott Gottlieb, the US Food and Drug Administration’s (FDA) new commissioner, addressed agency staff for the first time late Monday, telling them that "unquestionably, our greatest immediate challenge is the problem of opioid abuse."

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

Tags: Scott Gottlieb, FDA commissioner, opioids, 21st Century Cures

10 Hot-Button Issues FDA’s New Commissioner Will Face By Zachary Brennan - Published 11 May 2017

Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the US Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency.

Categories: News, Europe, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Scott Gottlieb, FDA commissioner, LDTs, Cures, opioids, off-label marketing, regulatory convergence

FDA Blueprint for Opioid Education Shifts Focus to Pain Patients By Michael Mezher - Published 09 May 2017

As the US Food and Drug Administration (FDA) weighs its options for improving healthcare provider training and education on prescribing opioids, the agency is proposing changes to its blueprint for opioid prescriber education.

Categories: News, US, FDA, Drugs

Tags: Opioids

Sen. Wyden to HHS: Upcoming FDA Opioid Meeting Full of Conflicts of Interest By Zachary Brennan - Published 08 May 2017

Sen. Ron Wyden (D-OR) is requesting that the US Food and Drug Administration (FDA) delay a workshop on opioids because of the financial conflicts between opioid manufacturers and those participating in the event, according to a letter sent Friday to HHS Secretary Tom Price.

Categories: News, FDA, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Wyden, Tom Price, HHS, FDA, opioids

When Does CDER Consult With Controlled Substance Staff? Revised MAPP Explains By Zachary Brennan - Published 07 March 2017

The US Food and Drug Administration (FDA) on Monday released a manual of policies and procedures (MAPP) outlining how its Center for Drug Evaluation and Research (CDER) staff consult with Controlled Substance Staff (CSS) on abuse potential and dependence liability.

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

Tags: CDER, CSS, controlled substances, opioids, opioid abuse

HHS Looks at New Ways to Track Adverse Events Linked to Anticoagulants, Diabetes Drugs and Opioids By Zachary Brennan - Published 19 October 2016

The US Department of Health and Human Services (HHS) on Wednesday proposed six new inpatient and outpatient measures to track as part of efforts to reduce adverse drug events (ADEs) from anticoagulants, diabetes agents and opioid analgesics.

Categories: News, US, FDA, Drugs, Government affairs, Quality

Tags: tracking adverse events, opioids, anticoagulants, diabetes drugs

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

Senators Question Pfizer, Mylan and Three Other Companies Over Opioid Overdose Treatment Price Hikes By Zachary Brennan - Published 07 June 2016

Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) sent five identical letters late last week to opioid overdose antidote manufacturers Pfizer, Amphastar Pharmaceuticals, Mylan, Kaléo Pharma and Adapt Pharmaceuticals with new questions on the companies’ price hikes of the life-saving drug naloxone, which has been marketed in the US for decades.

Categories: News, US, FDA, Business Skills, Drugs, Government affairs, Postmarket surveillance

Tags: Pfizer, naloxone, opioid overdose, Narcan, opioids

European Regulatory Roundup: EMA Plans Ways to Curb Antibiotic Resistance (2 June 2016) By Nick Paul Taylor - Published 02 June 2016

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

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Manufacturing, Veterinary products

Tags: EU Regulatory Roundup, antibiotic resistance, synthetic opioids

FDA: Generic Opioids Must be 'No Less' Abuse-Deterrent Than Brand-Name Versions By Michael Mezher - Published 24 March 2016

The US Food and Drug Administration (FDA) released a new draft guidance intended to ensure that generic versions of abuse-deterrent opioids meet the same standards for abuse deterrence as their brand-name counterparts for public comment on Thursday.

Categories: News, US, FDA, Crisis management, Generic drugs, Labeling, Postmarket surveillance, Submission and registration

Tags: Opioid epidemic, Opioids action plan, Abuse-deterrent formulation, ADF, OxyContin

Senate Democrats Call for FDA, NIH Funding Boost as Other Bills Emerge By Zachary Brennan - Published 04 March 2016

Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) on Thursday introduced a bill that would provide $5 billion per year in new funding for the Food and Drug Administration (FDA) and National Institutes of Health (NIH) as other legislation impacting FDA will be discussed and voted on in the coming week.

Categories: News, US, FDA, Drugs, Government affairs, Medical Devices, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: opioids, device regulation bill, pharmaceutical bill, FDA funding

State Health Officials Petition FDA for New Warnings on Opioids, Benzodiazepines By Zachary Brennan - Published 22 February 2016

Concerns over the risks of co-prescribing benzodiazepine and opioid drugs has 41 state health officials petitioning the US Food and Drug Administration (FDA) to place a new black box warning on both classes of pharmaceuticals to warn patients and doctors of the potential risks with concomitant use.

Categories: News, US, FDA, Combination products, Crisis management, Drugs, Due Diligence, Labeling, Postmarket surveillance

Tags: opioids, benzodiazepine, black box warning, boxed warning

FDA Calls for New Opioid Hearings as Califf Readies for Monday’s Senate Vote By Zachary Brennan - Published 19 February 2016

Three new expert committee meetings on opioids were announced by the US Food and Drug Administration (FDA) this week as two Democratic senators continue to oppose Robert Califf’s nomination as the next FDA commissioner ahead of a Senate vote on Monday.

Categories: News, US, FDA, Compliance, Crisis management, Postmarket surveillance, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: opioids and FDA, Califf, Senate vote for Califf, Manchin, Markey, Bernie Sanders

Updated: Governor Takes Issue With Super Bowl Drug Ad as New House Bill Looks to Restrict DTC Pharma Advertising By Zachary Brennan - Published 16 February 2016

Vermont Gov. Peter Shumlin (D) has sent a letter to pharmaceutical companies AstraZeneca and Daiichi Sankyo calling on them to pull their advertisement that aired during the Super Bowl. The ad promoted a drug to treat opioid-induced constipation.

Categories: News, US, FDA, Advertising and Promotion, Compliance, Crisis management, Drugs, Government affairs

Tags: Manchin, Markey, opioids, Califf, FDA, Valeant, AstraZeneca, Daiichi Sankyo

After Political Pressure, Califf Vows to Re-Examine FDA’s Opioid Policies By Zachary Brennan - Published 04 February 2016

President Barack Obama’s nominee to be the next commissioner of the US Food and Drug Administration, Dr. Robert Califf, on Thursday unveiled new policies aimed at “reversing” the opioid epidemic in the US.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Research and development

Tags: opioids, FDA, Senator Markey

New Law Redefines When Controlled Substances are Officially Approved By Zachary Brennan - Published 30 November 2015

Just before the Thanksgiving holiday weekend, President Barack Obama signed a new law that will effectively provide the pharmaceutical industry with more certainty on when controlled substances are officially approved.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: DEA, FDA approval, controlled substances, opioids

Legislators Press FDA to Add Black Box Warning to Immediate-Release Opioids By Alexander Gaffney, RAC - Published 08 June 2015

A group of nearly two dozen Democratic legislators is calling on the US Food and Drug Administration (FDA) to label immediate-release opioids with more serious warnings meant to reflect "the serious risks of abuse" associated with the drug.

Categories: News, US, CDER, Drugs, Labeling

Tags: Opioids, Labeling, Black Box, Legislators, Letter, ER Opioids, IR Opioids

Tougher FDA Approval Process for Opioids Sought by Congress By Alexander Gaffney, RAC - Published 16 April 2015

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA).

Categories: News, US, CDER, Drugs, Submission and registration

Tags: Opioids, Zohydro, Bill, Legislators, Senators, Senate, FDA Accountability for Public Safety Act

FDA Finalizes Approach to Abuse-Deterrent Opioids By Alexander Gaffney, RAC - Published 01 April 2015

Federal regulators have at long last finalized a policy which establishes voluntary guidelines by which manufacturers of opioid-based painkillers can prove that their products are resistant to misuse and abuse by patients.

Categories: News, US, CDER, Clinical, Drugs, Labeling, Postmarket surveillance

Tags: Opioids, Abuse-Deterrent Opioids, Guidance, Final Guidance

FDA to Publish Biosimilars Labeling, Generic Opioids Guidance Later This Year By Alexander Gaffney, RAC - Published 27 February 2015

US pharmaceutical regulators with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) say they plan to release two new guidance documents on, separately, the labeling of biosimilar products and how companies can evaluate abuse-deterrent properties of generic solid oral opioid drugs.

Categories: News, US, CDER, Biologics and biotechnology, Generic drugs, Prescription drugs

Tags: Biosimilar, Biosimilar Labeling, Opioids, Generic Opioids, Abuse-Deterrent Opioids, Guidance, Draft Guidance

Should FDA Pull Non-Abuse-Deterrent Generic Opioids off the Market? PhRMA, Bio Say Yes Published 20 January 2015

The US biopharmaceutical industry's two largest trade groups are calling on the US Food and Drug Administration (FDA) not to approve—or to revoke approval for—generic equivalents of older, non-abuse-resistant painkillers if a drug manufacturer has since made improvements to a drug to make it harder to abuse.

Categories: News, US, CDER, Generic drugs, Prescription drugs, Ethics, Submission and registration

Tags: Opioids, Generic Opioids, Generic Painkillers