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  • Regulatory NewsRegulatory News

    Abuse-Deterrent Opioids: FDA Finalizes Guidance for Generics

    The US Food and Drug Administration (FDA) last week finalized guidance detailing its expectations for drugmakers looking to develop generic versions of abuse-deterrent opioids. The guidance, which finalizes a draft issued in March 2016 , maintains that generic versions of abuse-deterrent opioids must be "no less abuse deterrent" than the drug they are referencing for all potential routes of abuse. According to guidance, this will help "minimize the risk of shifting abu...
  • Regulatory NewsRegulatory News

    FDA to Take Closer Look at Abuse-Deterrent Opioids

    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. At a two-day public workshop in July, FDA will meet with experts to look at how the agency can better evaluate the impact that abuse-deterrent opioids have on the growing epidemic. "We recognize that there is a gap in our understanding of whether these pro...
  • Regulatory NewsRegulatory News

    When Does CDER Consult With Controlled Substance Staff? Revised MAPP Explains

    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. Since 2000, CDER and CSS, which fulfills a unique role within FDA under the authority of the Controlled Substances Act (CSA) of 1970, have collaborated to evaluate all new drug applications (NDAs), abbrevia...
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    FDA Finalizes Guidance on Assessing Abuse Potential of Drugs

    A guidance finalized on Wednesday, almost six years after it was first drafted, looks to help sponsors of investigational new drugs in evaluating whether their new drug product has abuse potential. More specifically, the US Food and Drug Administration (FDA) says the 37-page guidance offers recommendations for assessing the abuse potential of central nervous system (CNS)-active new drugs and whether they produce euphoria (or other changes in mood), hallucinations, and ef...
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    FDA’s Approval of a New Abuse-Deterrent Opioid Raises Questions

    The US Food and Drug Administration (FDA) on Monday raised some eyebrows with its approval of another long-acting opioid, Egalet’s Arymo ER (morphine sulfate extended-release tablets), with abuse-deterrent properties. What makes this approval unique is not only the oddly-worded FDA explanation of an another opioid's marketing exclusivity in relation to this approval, but the agency overriding a nearly unanimous advisory panel of outside medical experts. Back in August,...
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    FDA Issues Untitled Letter for Website Promotion of an Opioid 10 Days Before PDUFA Date

    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 sites incorrectly suggest that the investigational new drug is safe and effective. The letter, dated 9 September for Cupertino, CA-based Durect and Austin-based Pain Therapeutics, comes a little more than two weeks b...
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    FDA: Generic Opioids Must be 'No Less' Abuse-Deterrent Than Brand-Name Versions

    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. The new draft guidance is part of a wider effort by FDA to address the national opioid epidemic, which claimed the lives of more than 28,000 Americans in 2014 . In February, the agency detailed its opioids action plan, sa...
  • Regulatory NewsRegulatory News

    FDA Finalizes Approach to Abuse-Deterrent Opioids

    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. Background The abuse of opioid painkillers in the US is a major problem. There were an estimated 16,235 opioid-related overdose deaths in the US in 2013, and recent studies have found that nearly a quarter of all patients on opioids misuse the dru...
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    FDA to Publish Biosimilars Labeling, Generic Opioids Guidance Later This Year

    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. News of the new guidance documents, which FDA anticipated will come out before the end of the year, came in an updated "Guidance Agenda" document the ...
  • FDA Looks for Stakeholder Input on Trials Meant to Assess Abuse of Opioids

    The US Food and Drug Administration (FDA) has experienced no shortage of criticism in recent years about its regulation of opioid-based painkillers in light of the drugs' contribution to what the Centers for Disease Control and Prevention (CDC) calls an " epidemic of prescription painkiller abuse ." But while FDA's fault (or lack thereof) is a matter of intense debate, the agency has nevertheless been taking steps in recent years meant to reduce abuse while maintaining a...
  • FDA Looks to Technology to Help it Get a Handle on Opioid Abuse

    The US Food and Drug Administration (FDA) has had no shortage of critics of its regulation of opioid analgesics, including a controversial decision in 2013 to approve Zohydro (hydrocodone bitartrate), a pure hydrocodone product notable for its lack of either acetaminophen or abuse-deterrent qualities. But after facing withering criticism and mounting pressure from legislators and even state regulators, FDA is moving to try to establish a constructive dialogue on how it c...
  • FDA Says Abuse-Deterrence Equivalence Guidance is Under Development

    The US Food and Drug Administration (FDA) has announced it intends to issue a guidance document regarding the equivalence of abuse-deterrent qualities between generic and branded versions of Purdue Pharma's Oxycontin, laying a pathway to approval for future generic market entrants-and perhaps other types of drugs as well. Background In April 2013, FDA announced that it had determined that an original, non-abuse-deterrent version of Oxycontin (oxycodone hydrochloride) ...