RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • 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

    Drugmakers Debate Whether Parts of FDA’s Biosimilar Guidance are Unconstitutional

    Drugmakers and trade groups have raised questions with two US Food and Drug Administration (FDA) guidance documents on biosimilars, including one explaining how FDA plans to transfer drugs previously approved under new drug applications (NDAs) to be biologic license applications (BLAs). On this so-called “Deemed to be a License” guidance , which explains the NDA to BLA transition, all but one of the biopharma companies and industry groups took issue with the agency’s a...
  • 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

    FDA’s Biosimilars Workload: 57 Development Programs, $81M Spent in First Three Fiscal Years

    A new independent analysis of the US Food and Drug Administration's (FDA) workload around biosimilars over the first three years shows how biosimilar development has slowly progressed as companies continue to seek more meetings with FDA on specific issues and targeted advice. As of 30 September 2015, the report says there are 57 programs participating in the biosimilar product development program (up from 33 in FY 2013 and 48 in FY 2014), and a total of seven Biologics L...
  • Regulatory NewsRegulatory News

    FDA Briefing Documents Offer Support for Remicade Biosimilar

    The US Food and Drug Administration (FDA) on Friday unveiled briefing documents that could support the approval of Celltrion’s proposed Remicade (infliximab) biosimilar ahead of next Tuesday’s advisory committee hearing. The 73-page document offers new insight into what Celltrion submitted to support the licensure of its biosimilar, known as CT-P13, for Johnson and Johnson’s reference product, and FDA officials noted that the two products are “highly similar,” though th...
  • Regulatory NewsRegulatory News

    FDA Likely to Require Substantial Clinical Data for Interchangeable Biosimilars, Lawyers Say

    The US Food and Drug Administration (FDA) is “almost certain” to require clinical data in order for companies to demonstrate interchangeability between a biosimilar and its reference product, though the question of how much data will be required is major factor in determining how quickly the US biosimilars market will take off, according to a new report from the law firm Goodwin Procter. The Biologics Price Competition and Innovation Act (BPCIA) of 2010 established th...
  • Regulatory NewsRegulatory News

    FDA Workload, Spending on Biosimilars Program Picks Up in 2015, Report Says

    In the first two and a half years of the US Food and Drug Administration (FDA)’s biosimilars review program, the agency is only recently starting to ramp up spending and manpower, according to an interim report from Eastern Research Group (ERG) released Wednesday. Background Under the Biosimilar User Fee Act (BsUFA), enacted by Congress in 2012, FDA was required to contract with an independent consulting firm to develop an estimate of the workload volume and full costs ...
  • Regulatory NewsRegulatory News

    FDA Receives First-Ever Biosimilar Application for Monoclonal Antibody

    South Korean biopharmaceutical manufacturer Celltrion has announced that it has filed an application for approval with the US Food and Drug Administration (FDA) for Remsima, its biosimilar version of Jannsen's Remicade (infliximab). The company's biosimilar filing is the second-ever filing of a drug through FDA's new 351(k) biosimilar pathway, and reportedly the first-ever monoclonal antibody (mAb) to seek approval through the pathway. The first biosimilar filing for ...
  • Regulatory NewsRegulatory News

    Sandoz First Company to File for Biosimilar Approval in US Under New Pathway

    Biopharmaceutical company Sandoz, a Novartis subsidiary, has announced that it has filed the first-ever biosimilar application in the US with the Food and Drug Administration (FDA) using its 351(k) pathway. Sandoz Statement The company's announcement, made 24 July 2014, says FDA has already accepted its filing for a biosimilar Neupogen (filgrastim), an FDA-approved treatment used to decrease rates of infection in patients with nonmyeloid malignancies who are already r...