• Feature ArticlesFeature Articles

    A deep dive into OPDP’s position on public health emergencies in the US

    This article explores the Office of Prescription Drug Promotion’s (OPDP’s) views on public health emergencies, including COVID-19, and how this affects drug promotion. The author reviews trends in past enforcement letters and concludes that promotional materials relating to current public health emergencies are heavily scrutinized by OPDP, which regulatory advertising and promotion reviewers should bear in mind.   Introduction The COVID-19 pandemic has caused innumer...
  • Regulatory NewsRegulatory News

    MHRA Consults on Analytical Quality by Design Principles

    The UK’s Medicines and Health care products Regulatory Agency (MHRA) on Tuesday opened a three-month public consultation on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeial standards.   “Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management,” MHRA writes.   Th...
  • Regulatory NewsRegulatory News

    Health Canada Opens Generic Drug Guidances for Consultation

    Health Canada last week released two draft guidances for public consultation as part of the agency’s effort to clarify the criteria for its abbreviated new drug submission (ANDS) pathway for generic drugs.   Specifically, the draft guidances detail how the agency intends to implement a recently proposed regulatory amendment aimed at boosting access to generic drugs and making labeling more consistent and transparent.   “The draft guidance documents have been releas...
  • Regulatory NewsRegulatory News

    Public Citizen, FDA Advisor Call for Moratorium on Opioid Approvals

    Nonprofit advocacy group Public Citizen on Thursday filed a citizen petition calling for the US Food and Drug Administration (FDA) to impose a moratorium on approving new or reformulated opioids until the agency implements recommendations from a 2017 report by the National Academies of Science, Engineering and Medicine.   The petition is undersigned by Raeford Brown, the chair of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee who has spoken out again...
  • Regulatory NewsRegulatory News

    FDA Inspection Finds Minnesota Hospital Violated Informed Consent, IRB Rules

    In an inspection report obtained by Public Citizen, the US Food and Drug Administration (FDA) cites the Hennepin County Medical Center over its institutional review board’s (IRB) oversight of clinical trials that involved dosing emergency patients with ketamine and other sedatives without the patients’ consent.   The inspection, which ran from 7-24 August, came after the Star Tribune reported on clinical trials conducted by the hospital and just weeks after Public C...
  • Regulatory NewsRegulatory News

    FDA Launches Searchable Adverse Event Database for Drugs and Biologics

    The US Food and Drug Administration (FDA) on Wednesday launched a new searchable public dashboard for its adverse event database for drugs and biologics. Known as FAERS (FDA's Adverse Event Reporting System), the database contains some 14 million adverse event reports submitted to FDA by healthcare professionals, consumers and manufacturers for drugs and biologics. Its immediate release led to questions over certain deaths , whether they were linked to the drug's safety...
  • Regulatory NewsRegulatory News

    Public Citizen Sues FDA Over OTC Drug Risks

    Nonprofit Public Citizen on Thursday sued the US Food and Drug Administration (FDA) alleging that the agency has failed to act on safety issues related to the over-the-counter (OTC) drug benzocaine. The lawsuit, filed on the grounds that FDA is in violation of the Administrative Procedures Act for "withholding or unreasonably delaying action" on a citizen petition filed by Public Citizen in 2014 that calls on the agency to add a warning that benzocaine can cause ...
  • New Study Says 63% of US Adults Trust FDA

    A study published Tuesday in PLOS reveals that the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) might have more work to do to ensure Americans trust them. In a study of more than 5,000 adults and 1,100 adolescents, the researchers from the University of North Carolina found that among adults, awareness of CDC and FDA was high (83.6% and 94.3%, respectively) but adults’ trust in the agencies was lower, with 64.6% reported...
  • Regulatory NewsRegulatory News

    Public Citizen Warns 'Right to Try' Gives Patients False Hope

    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. In recent years more than 30 states have adopted right to try laws that seek to provide terminally ill patients access to unapproved drugs, with several new congressional efforts to create a federal right to try program. The White House has signaled...
  • Regulatory NewsRegulatory News

    Public Citizen Petitions FDA to Pull Some IV Solutions

    Consumer advocacy organization Public Citizen on Wednesday petitioned the US Food and Drug Administration (FDA) to immediately require the removal of hydroxyethyl starch (HES) intravenous (IV) solutions from the market because their risks outweigh their limited benefits and there are other, safer alternative IV solutions. According to the petition, there are two main categories of IV solutions: crystalloid and colloid. Colloidal solutions, including HES, have largely the...
  • Regulatory NewsRegulatory News

    FDA’s CDER Lays Out Rules for Public-Private Partnerships

    The US Food and Drug Administration (FDA) on Friday published a manual of policies and procedures (MAPP) describing how staff from the Center for Drug Evaluation and Research (CDER) can engage in public-private partnerships and consortia to facilitate, inform, and help the external groups understand CDER’s current thinking in a role separate from any regulatory review process. Under FDA’s Critical Path Initiative , Advancing Regulatory Science Initiative and similar ...
  • Regulatory NewsRegulatory News

    FDA Withdraws Proposed Rule on Public Disclosure of Info on Unapproved Gene Therapies

    The US Food and Drug Administration (FDA) on Thursday announced it is withdrawing a proposed rule from 2001 that would have required the public disclosure of summaries of safety and effectiveness data, in addition to other information, from pre-market clinical trials of gene therapies and transplanted non-human tissues to humans, known as xenotransplantation. “FDA has reconsidered our position on this issue and deemed our concerns from 2001 outdated. We will continue to ...