RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

  • Regulatory NewsRegulatory News

    FDA officials discuss prioritizing inspections, QMSR transition

    Officials from the US Food and Drug Administration (FDA) explained how the agency is prioritizing medical device inspections as it resumes normalized operations. They also announced a new “careful and cautious” approach to conducting foreign inspections.   At the 4 May virtual MedCon Conference which was hosted by the Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS), officials also addressed how it will balance the u...
  • Regulatory NewsRegulatory News

    Unannounced FDA inspections have started in India, not China

    The US Food and Drug Administration (FDA) unannounced foreign inspections program has resumed in India but is still paused in China due to local COVID-19 restrictions, Judith McMeekin, FDA associate commissioner for regulatory affairs, said on 6 April during a webinar sponsored by the Alliance for a Stronger FDA.   Members of Congress have expressed concern that FDA’s drug inspection program is inadequate to meet the meet the growth in foreign drug manufacturing facili...
  • Regulatory NewsRegulatory News

    FDA resuming normalized operations but will continue to leverage MRAs

    As the US Food and Drug Administration (FDA) returns to normalized operations with onsite inspections, it will continue to take a risk-based approach in determining which firms are inspected next and continue to rely on mutual recognition agreements (MRAs) with other countries in assessing pharmaceutical facilities, according to Alonza Cruse, director of FDA’s pharmaceutical quality operations.   Cruse discussed how the agency is transitioning to normal operations on 1...
  • Regulatory NewsRegulatory News

    FDA extends temporary halt in inspections driven by omicron

    The US Food and Drug Administration (FDA) has extended its temporary pause on non-mission-critical domestic surveillance inspections through 4 February 2022, an agency spokesperson told Focus on Wednesday.   FDA previously announced it would halt certain inspectional activities out of concern for its employees and those of the companies it regulates amid the wave of COVID-19 infections driven by the omicron variant. At the time, the agency said it would continue to c...
  • Regulatory NewsRegulatory News

    FDA addresses establishment of inspection programs for injectables

    The US Food and Drug Administration (FDA) on Thursday issued a draft guidance to help manufacturers set up inspection testing programs to ensure that their injectable drugs are free of visible particles.   The 18-page draft guidance "addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inpsection techniques, particulate identification, inves...
  • Regulatory NewsRegulatory News

    Unannounced FDA inspections in India, China to begin soon

    An official with the US Food and Drug Administration (FDA) announced the agency will soon resume unannounced onsite inspections in India and China. Also, prioritized foreign inspections will resume in February.   Elizabeth Miller, assistant commissioner for medical products and tobacco operations in FDA’s Office of Regulatory Affairs (ORA), provided this update on the agency’s inspection activities at a 9 December virtual conference on enforcement sponsored by the Fo...
  • Regulatory NewsRegulatory News

    ICMRA: Remote inspections can complement, but not replace, onsite inspections

    While there are benefits to conducting remote good clinical practice (GCP) and good manufacturing practice (GMP) inspections and these assessments can continue being used  post pandemic, these methods have their limitations, concludes the International Coalition of Medicines Regulatory Authorities (ICMRA) in a new reflection paper .   Among the topics ICMRA touches on in the reflection paper are the decision-making process to use remote approaches, tools for remote in...
  • Regulatory NewsRegulatory News

    FDA: No plans yet to resume onsite GMP foreign inspections

    An official with the US Food and Drug Administration (FDA) said the agency has no plans to resume onsite foreign inspections for operations that are not deemed “mission critical” during the COVID-19 public health emergency. Instead, the agency is relying on the expanded use of mutual recognition agreements as an alternative tool for boots-on-the-ground inspections.   So asserted Alonza Cruse, the director of pharmaceutical quality operations in FDA’s Office of Regulato...
  • Regulatory NewsRegulatory News

    FDA-registered sites declined in 2020: OPQ drug quality report

    A new report from the US Food and Drug Administration's (FDA's) Office of Pharmaceutical Quality (OPQ) shows a small drop overall in drug manufacturing sites and a shift toward pandemic-related priorities in FY 2020.   The OPQ report on the state of pharmaceutical quality for FY 2020 notes that drug manufacturing sites included in FDA’s site catalog declined by just over 1% in FY 2020 to 4,221. Medical gas manufacturers are excluded from this figure, as are the crop ...
  • Regulatory NewsRegulatory News

    FDA’s regulatory affairs head previews Inspectional Affairs Council

    The top regulatory affairs official at the US Food and Drug Administration (FDA) gave a preview of a soon-to-be-launched council within the agency that will focus solely on inspection-related matters.   “We will soon stand up an agency-wide decision-making body; it’s called the FDA Inspectional Affairs Council,” said Judith McMeekin, FDA’s associate commissioner for regulatory affairs within the Office of Regulatory Affairs (ORA), speaking at a virtual webinar hosted W...
  • Regulatory NewsRegulatory News

    FDA gives generics updates at DIA town hall

    Officials at the US Food and Drug Administration (FDA) addressed plans to prioritize on-site inspections and gave updates regarding certain new drug applications during a generics-focused virtual town hall convened by the Drug Information Association (DIA) as part of its virtual annual meeting. During the session, regulators also shared post-pandemic learnings, including the importance of international collaborations for generic drug development.   The session inclu...
  • Regulatory NewsRegulatory News

    Pharmaceutical officials propose new USP harmonized chapter on visual inspections

    Pharmaceutical industry officials have proposed the United States Pharmacopeia (USP) develop a new harmonized chapter on visual inspections of parenteral drugs that would address current testing gaps. This chapter would be developed with input from the European Pharmacopeia and the Japanese Pharmacopeia. Such a chapter would allow for more robust detection of visible particles in these drugs, which is a common reason for reason for recalls and warning letters in the US,...