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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Feature ArticlesFeature Articles

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    Australia’s TGA Issues Amended Nonclinical Studies Guidance

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) this week (15 September 2014) issued  an amended guidance on nonclinical studies for Module 4 of the  Common Technical Document  (CTD), which is an integral part of an application to register a prescription medicine on...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    FDA Looks to Improve Generic Drug Submission Quality in New Guidance

    The US Food and Drug Administration (FDA) has released a new draft guidance document on the content and format of generic drug submissions using the common technical document (CTD). Background Generic drug applications are regulated under Section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) , and are submitted to FDA using an Abbreviated New Drug Application (ANDA). A successful application will show that a drug is the same (as defined by FDA) as ...
  • 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...
  • 'Major Updates' to eCTD Module 1 Released by FDA

    The US Food and Drug Administration (FDA) has announced the release of "major updates" to Module 1 of the electronic common technical documents (eCTD), used to supplement all eCTD submissions in the US with specific information required by FDA. The two documents, The eCTD Backbone Files Specification for Module 1, version 2.0 and Comprehensive Table of Contents Headings and Hierarchy, version 2.0. , are available on FDA's website along with other supporting tec...