• Feature ArticlesFeature Articles

    Drug preclusion and public health: The case for a narrow interpretation of ‘article’

    The definition of “dietary supplement” in the Food, Drug, and Cosmetic (FD&C) Act includes several provisions limiting what can be a legal dietary supplement based on the ingredients used and delivery form, as well as whether a substance has a history of drug use. This article explores the US Food and Drug Administration’s (FDA’s) use of this last provision, often called “drug preclusion.” The authors examine the history of the provision, Congress’s purported purpose for ...
  • Regulatory NewsRegulatory News

    EU issues long-awaited GMP Annex 1 revision

    The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years of development. The revised requirements, which are set to take effect 25 August 2023, govern the manufacturing of sterile drugs made in the EU, as well as imported products.   The revised Annex comes after hints earlier this year that it be out in mid-2022. (RELATED: EU GMP Annex 1 revision to be released mid-year ...
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    FDA rolls out more guidance on 'N of 1' gene therapies

    Developers of individualized investigational antisense oligonucleotide (ASO) therapies for ultra-rare diseases received additional guidance from the US Food and Drug Administration (FDA). In two draft documents, the agency has provided new information for sponsor-investigators and for those overseeing manufacture of these so-called “N of 1” therapies for people with severely debilitating or life-threatening genetic disease.   "Progress in individualized medicines provi...
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    Edwards Recalls Part of Transcatheter Heart System After One Death

    Last month, Edwards Lifesciences recalled its SAPIEN 3 Ultra Delivery System after reports of burst balloons during implantation, resulting in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient, the US Food and Drug Administration (FDA) said Thursday. FDA said 17 injuries and one death were reported at the time when Edwards initiated the Field Corrective Action early last month. “The use of affected product may caus...
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    European Commission Consults on Revised GMPs for Sterile Drugs

    The European Commission on Wednesday launched a three-month public consultation ahead of its planned revision to good manufacturing practice (GMP) rules for sterile medicinal products contained in Annex 1 of Eudralex Volume 4 . The Commission says the revision was developed in cooperation with the World Health Organization (WHO) and the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), and is meant to add clarity to Annex 1, which has been updated numerous times si...
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    Overview of Annex I, In Vitro Diagnostic Directive and the new In Vitro Diagnostic Regulation

    This article provides an overview of Annex I, Essential Requirements 98/79/EC and helps clarify understanding of the new content of Annex I, General Safety and Performance Requirements. It is aimed at regulatory professionals who will benefit from having knowledge of In Vitro Diagnostic Medical Devices General Requirements and Essential Requirements (ERs) as well as requirements for risk management, software, labeling, self-testing devices and instructions for use. Int...
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    FOIA'd Documents Show FDA's Rationale Against Marijuana Rescheduling

    In a report and other documents obtained by Vice News via the Freedom of Information Act (FOIA) , the US Food and Drug Administration (FDA) lays out its case against rescheduling marijuana. FDA's recommendation on the matter was cited by the Drug Enforcement Administration (DEA) when it denied two petitions to reschedule marijuana last August . Despite efforts by medical marijuana advocates and a growing number of states (25, plus the District of Columbia) where med...
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    FDA: Toxicity Seen in Fatal French Study Does Not Extend to Other FAAH Inhibitors

    The U.S. Food and Drug Administration (FDA) on Friday said that after reviewing the safety information of a first-in-human clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January, the agency found that the toxicity exhibited in the trial does not extend to other drugs in the class, known as fatty acid amide hydrolase (FAAH) inhibitors. Working alongside the European Medicines Agency (EMA) and ...
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    FDA Clarifies how Generic Drug Companies can Change Their Manufacturing Processes

    A new guidance document issued by the US Food and Drug Administration's (FDA) drug and biologics review divisions explains how the agency handles Prior Approval Supplements (PAS) under its generic drug user fee amendments (GDUFA) program. Background A PAS is an application which seeks to make changes to an already-approved application , such as an Abbreviated New Drug Application (ANDA), which is used by FDA to approve generic drugs. Unlike other change notification ...
  • As GSK Recalls Weight Loss Drug After Tampering, A Focus on Limits of the DQSA

    Did legislators go far enough in their attempts to secure the pharmaceutical supply chain when passing the Drug Quality and Security Act (DQSA) last year? That question is now on the minds of some after pharmaceutical manufacturer GlaxoSmithKline issued a massive recall of all lots of its over-the-counter weight loss drug Alli (orlistat capsules) following a determination that some lots of the drug had been " tampered with ." While the DQSA contains extensive requir...
  • eCTD Revisions Published by FDA, Set for June 2014 Adoption

    In recent years, the electronic Common Technical Document (eCTD) has become the application type of choice for regulatory professionals operating in the US, EU, Japan and many other markets, offering them a relatively straightforward way to file small variations on a single application to multiple regulatory bodies. Now the US Food and Drug Administration (FDA) has announced the publication of final versions of several documents outlining specifications used in the eCTD's...
  • Health Canada Overhauls Guidance for eCTD Module

    Health Canada has released a new guidance document pertaining to the creation of the Canadian Module 1 backbone of the electronic Common Technical Document (eCTD), a standardized pharmaceutical review application format created by the International Conference on Harmonisation (ICH). Canadian regulators explained that the new guidance replaces an earlier 2004 guidance of a similar name, and outlines the process by which industry can create a regional backbone file. The fi...