Search Results for Opioid Epidemic

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Gottlieb: Next Steps in Opioid Crisis May be 'Uncomfortable' By Michael Mezher - Published 25 October 2017

In testimony before the House Energy & Commerce Committee on Wednesday, FDA Commissioner Scott Gottlieb said that the next steps in efforts to combat the ongoing opioid crisis will be difficult, but necessary given the spread of the epidemic.

Categories: News, US, FDA, Drugs

Tags: Opioid Epidemic, Drug Overdose, Medication-Assisted Treatment, Scott Gottlieb

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

FDA Calls to Remove Endo Opioid From US Market By Zachary Brennan - Published 09 June 2017

The US Food and Drug Administration on Thursday requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market due to public health concerns over abuse.

Categories: News, US, FDA, Drugs

Tags: opioid, opioid epidemic, RoxyBond, Opana ER

Former Insys Executives Arrested on Racketeering Charges By Michael Mezher - Published 08 December 2016

Six former Insys Therapeutics executives and managers were arrested on Thursday on charges that they conspired to bribe healthcare practitioners to prescribe the company's fast-acting fentanyl spray Subsys.

Categories: News, US, DOJ, Drugs

Tags: Insys, Department of Justice, Kickbacks, Subsys, Opioid Epidemic

FDA Calls for Boxed Warning on Two Drug Classes By Michael Mezher - Published 31 August 2016

The US Food and Drug Administration (FDA) says it is requiring two classes of drugs, opioids and benzodiazepines, to bear a boxed warning over serious and sometimes fatal risks when the two drugs are used in combination.

Categories: News, US, FDA, Drugs, Labeling

Tags: Opioid, Benzodiazepine, Overdose, Opioid epidemic, Boxed Warning

Obama Expands Buprenorphine, Naloxone Use to Fight Opioid Epidemic By Michael Mezher - Published 29 March 2016

President Barack Obama on Tuesday introduced new measures to expand access to drugs used to treat opioid addiction.

Categories: News, US, FDA, Drugs

Tags: Naloxone, Buprenorphine, Opioid epidemic

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

OTC Opioid Overdose Antidote: Why is it not FDA Approved? By Zachary Brennan - Published 24 February 2016

The case of the opioid overdose antidote naloxone (also known as Narcan) offers an interesting look at how states can offer a prescription drug without a prescription at local pharmacies, even though the US Food and Drug Administration (FDA) has not approved it as an over-the-counter drug.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Labeling, Medical Devices, Product withdrawl and retirement, Research and development

Tags: opioid, heroin overdose, naloxone, opioid epidemic, opioid deaths

Dramatic Drop in Hydrocodone Combo Prescriptions After DEA Rescheduling By Michael Mezher - Published 27 January 2016

Prescriptions for hydrocodone combination products (HCPs) fell significantly after the US Drug Enforcement Agency (DEA) tightened restrictions on those drugs, according to a study published Monday in JAMA Internal Medicine.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Prescription drugs, Government affairs

Tags: Hydrocodone, Opioid epidemic, Schedule II, DEA, Drug Enforcement Agency