• Regulatory NewsRegulatory News

    FDA Adds New Q&As to Lab Controls Section of CGMP Guidance

    The US Food and Drug Administration (FDA) on Wednesday added three new questions and answers to its Laboratory Controls questions and answers (Q&A) on Current Good Manufacturing Practices (CGMP) guidance. The new Q&As discuss instrument calibration standards for chromatographic systems, system suitability and trial injections.   On the issue of trial injections, where a sample of a lot is injected into the chromatographic system with the intention of obtaining an unoff...
  • Regulatory NewsRegulatory News

    FDA Leadership Calls for LDT Reforms

    While championing advances made in diagnostic technology in recent years, top officials from the US Food and Drug Administration (FDA) are calling for a new regulatory framework for in vitro clinical tests (IVCTs) and laboratory developed tests (LDTs). The call comes as lawmakers from both parties on Thursday released a new 200-page discussion draft of a bill that would establish such a framework, incorporating many of the reforms FDA has recommended, including a pr...
  • Regulatory NewsRegulatory News

    FDA Hands Akorn 483 Over GMP Issues at New Jersey Site

    In an inspection report released Friday, the US Food and Drug Administration (FDA) details 11 observations from an inspection of Akorn’s Somerset, New Jersey facility in July and August of this year.   This is the second Form 483 Akorn has received in 2018. In May the company was handed a Form 483 listing a total of 13 observations from an inspection of the company’s Decatur, IL facility, the third inspection report issued for that facility in three years.   Form ...
  • Regulatory NewsRegulatory News

    MDSAP Changes Aim to Reduce Audit Times

    With an eye on a 1 January 2019 deadline for transitioning to only Medical Device Single Audit Program (MDSAP) quality management system certificates accepted for medical device license applications by Health Canada, the MDSAP consortium has implemented a couple of changes to speed up audits. The changes follow comments received by Health Canada from Canadian medical device license holders regarding the current audit-time model for MDSAP and subsequent annual survei...
  • Regulatory NewsRegulatory News

    510(k) Third Party Review Program: FDA Offers New Draft Guidance

    The US Food and Drug Administration (FDA) on Friday issued new draft guidance updating the agency’s current thinking on a program used to accredit third parties to review premarket notification (510(k)) submissions for medical devices and recommend the initial classification of certain devices. In an effort to encourage harmonization, the guidance refers to standards described in the International Medical Device Regulators Forum (IMDRF) documents as criteria FDA will con...
  • Regulatory NewsRegulatory News

    Device Industry Calls for Clarifications to Draft Animal Studies Guidance

    The Advanced Medical Technology Association (AdvaMed) is calling on the US Food and Drug Administration (FDA) to clarify aspects of a recent draft guidance intended to set expectations for animal studies for medical devices. Draft Guidance FDA released the draft guidance, General Considerations for Animal Studies , for public comment in October 2015. The guidance is intended to assist industry in designing, conducting and reporting data from animal studies used to de...
  • Regulatory NewsRegulatory News

    Two More Companies Questioned by FDA Over DTC Genetic Tests

    The US Food and Drug Administration (FDA) sent letters to two genetic testing companies for marketing direct-to-consumer pharmacogenetics tests. The letters, addressed to Healthspek and Genomic Express, claim that tests sold through the companies' websites meet the definition of a medical device and must be cleared by FDA before being marketed. FDA Letters to Genetic Testing Companies Company Test Name Indication or Claim Genomic Express  Clopidogrel (Pl...
  • Regulatory NewsRegulatory News

    FDA Defends Plans to Regulate LDTs at House Hearing

    The US Food and Drug Administration (FDA) is making it clear to Congress that it's up to the task of regulating lab developed tests (LDTs). Speaking at a House Energy & Commerce Committee hearing today, Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH) defended the agency's plan saying, "Getting the right treatment to the right patient at the right time depends on having accurate, reliable and clinically validated tests." Unlike traditi...
  • Regulatory NewsRegulatory News

    FDA Warns Three Companies Over DTC Genetic Tests

    Last week, the US Food and Drug Administration (FDA) sent letters to three genetic testing companies for marketing unapproved direct-to-consumer (DTC) tests. The letters are addressed to three companies: DNA4Life, DNA-CardioCheck, Inc. and Interleukin Genetics, Inc., which FDA says are marketing genetic tests to consumers without being cleared. In each of the letters, James Woods, FDA Deputy Director for the Patient Safety and Product Quality Office of In Vitro Diagnost...
  • Regulatory NewsRegulatory News

    USP Signs Agreement With Russian Drug Regulator to Continue Developing Quality Standards

    USP CSO Jaap Venema (right) signs agreement with Russian FDA Roszdravnadzor. The US Pharmacopeial Convention (USP) and Russia's medical products regulator forged a three-year memorandum of understanding (MOU) earlier this week that will focus on harmonizing major pharmacopeial requirements and promoting the use of modern laboratory standards, among other things. The agreement, which is an extension of an existing MOU instituted in 2009, means USP and the Federal...
  • Regulatory NewsRegulatory News

    FDA Calls Out Pathway Genomics for Marketing Unapproved Cancer Test

    Pathway Genomics is currently marketing an unapproved screening tool, which the US Food and Drug Administration (FDA) believes to be a medical device, for the early detection of up to 10 different cancer types, the agency said in a letter to the company this week. FDA says that the non-invasive blood test, known as CancerIntercept Detect, "appears to meet the definition of a device" as the company ships blood collection tubes, a medical device, for use with the tool. "W...
  • Regulatory NewsRegulatory News

    EMA Updates Two Pharmacovigilance Guidelines

    Today, the European Medicines Agency (EMA) released two revised guidelines, one final and one draft, to clarify certain aspects of pharmacovigilance in the EU. The two guidelines include a draft version of Module VIII – Post-Authorisation Safety Studies (Rev 2) , which is expected to come into effect in early 2016, and Module IV – Pharmacovigilance Audits (Rev 1) , which takes effect on 12 August 2015. Background Pharmacovigilance is the process of monitoring the use...