The Learning Portal will be under maintenance Friday, 28 January from 10PM to 12AM. Portal functionality may be unavailable intermittently during this window.
We apologize for any inconvenience caused during this time.

  • Regulatory NewsRegulatory News

    Industry Argues Against FDA Home-Use Device Label Database

    The Advanced Medical Technology Association (AdvaMed) is at odds with a recent proposal by the US Food and Drug Administration (FDA) to create a public facing electronic database for home-use medical device labels. In October, FDA announced the proposed rule , which would require the makers of Class II and Class III medical devices intended for home-use to submit the labels and package inserts for their products electronically. These electronic labels and package insert...
  • Regulatory NewsRegulatory News

    FDA Officials Call for Including Adolescents in Adult Oncology Trials

    A team of officials at the US Food and Drug Administration (FDA) are calling for a "culture shift" by drugmakers, regulators and clinical investigators to encourage enrolling more adolescent patients in relevant "adult-type" cancer clinical trials. The officials made the call in a recent article in Clinical Cancer Research , where they argue that excluding older adolescents, ages 12 to 17, from adult oncology trials leads to delayed access to new treatments for those pa...
  • Regulatory NewsRegulatory News

    FDA Begins Consultation on Update to ICH Pediatric Clinical Trials Guidance

    The US Food and Drug Administration (FDA) on Monday launched a three-month public consultation on an addendum to the International Council for Harmonisation's (ICH) guidance on pediatric clinical trials. The addendum, E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population , is intended to supplement ICH's E11 guidance by expanding  the discussion on issues related to pediatric clinical trials in light of scientific and regulatory ...
  • Regulatory NewsRegulatory News

    FDA Looks to Decrease Adverse Events With New Home-Use Device Label Database

    As part of efforts to reduce an increasing number of adverse events from home-use medical devices, the US Food and Drug Administration (FDA) is proposing to create an online database of all such device labels and to require companies to submit the labels and package inserts in an electronic format.  The shift comes as FDA reviewers claim that the agency receives reports of approximately three to five of the most serious types of adverse events (deaths, fires, explosions...
  • Regulatory NewsRegulatory News

    Priority Review Voucher Fees to Decline in FY 2017

    The US Food and Drug Administration (FDA) on Thursday unveiled the new user fee rates for the tropical disease and rare pediatric disease priority review voucher (PRV) programs. The additional fees necessary to use the vouchers for both programs are set to decline by about $20,000 when compared to last year. Tropical Disease Priority Review Voucher User Fee Year Voucher Fee FY 2011 $4,582,000 FY 2012 $5,280,000 FY 2013 $3...
  • Regulatory NewsRegulatory News

    Congress Signs Off on Short-Term Extension to Rare Pediatric PRV Program

    The House late Tuesday followed its Senate counterparts and sent to President Barack Obama a re-authorization of the rare pediatric disease priority review voucher (PRV) program that will last through the end of December. A spokeswoman for Sen. Bob Casey (D-PA), a sponsor of the bill, told Focus that between now and 30 December, Congress will discuss ways to amend the program and extend it again. “Our policy changes are in S. 1878, which is headed to the president, so...
  • Regulatory NewsRegulatory News

    Pediatric Priority Review Vouchers on the Chopping Block as Reauthorization Stalls

    Congress and President Barack Obama have one week to reauthorize the rare pediatric priority review voucher (PRV) program or else it will end on 30 September 2016, after seven pediatric PRVs have been awarded, one of which sold for $350 million last year. The PRV program offers vouchers that companies can win for gaining approval of new rare pediatric treatments, affecting fewer than 200,000 patients under the age of 18. The vouchers can be used to speed FDA’s review ...
  • Regulatory NewsRegulatory News

    UK’s MHRA Introduces Re-Manufacturing of Single-Use Devices

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that single-use medical devices may be re-manufactured for use in the UK, though the remanufacturers should meet all relevant criteria under the appropriate device directives and place a CE mark on their product. The shift to allow such re-manufacturing comes with new guidance from MHRA, which notes that the re-manufacturing of single-use devices and similar processes have existed outsid...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Extrapolating Data for Pediatric Medical Devices

    A little more than a year after introducing the draft version, the US Food and Drug Administration (FDA) on Monday finalized guidance on how and when it may be appropriate to leverage existing clinical data to support pediatric medical device indications and labeling. The guidance, which, like the draft from May 2015 , reveals FDA’s concerns with the paucity of scientific evidence substantiating medical device submissions for pediatric indications, outlines ways in whic...
  • Regulatory NewsRegulatory News

    European Commission Unveils Four New Public Consultations on Clinical Trials

    The four new consultations, released Thursday from the European Commission, deal with ethical considerations for pharmaceutical trials with minors, risk proportionate approaches in trials, summaries of trial results for non-specialists or “laypersons” and definitions of investigational medical products (IMPs) and use of auxiliary medicinal products (AMPs). The consultations offer respondents a chance to weigh in (comments on the four consultations are due by 31 August) o...
  • Regulatory NewsRegulatory News

    FDA Looks to Revitalize Compassionate Use Program With Simplified Form, Final Guidance

    The US Food and Drug Administration (FDA) on Thursday finalized two question and answer guidance documents on charging for investigational drugs and expanded access for the compassionate use of investigational drugs for those with life-threatening diseases or conditions, as well as a new streamlined form for applying for expanded access. The new form, known as the Form FDA 3926, is part of an expedited process to help patients gain access to drugs that are still in clini...
  • Regulatory NewsRegulatory News

    Off-Label Drug Use and Pharmacovigilance: EMA Outlines What MAHs Need to Collect and Report

    Pharmaceutical companies operating in the EU will need to collect and report information on the off-label use of their medicines under new obligations making their way from draft to final form at the European Medicines Agency (EMA) this summer. In late April, EMA offered a reflection paper , open for comment through 29 July, which offers the agency’s proposal for the collection and reporting of information on off-label use for marketing authorization holders (MAHs), in ...