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...

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...

The US Food and Drug Administration (FDA) on Thursday issued a draft guidance to help manufacturers set up inspection testing programs to ensure that their injectable drugs are free of visible particles.   The 18-page draft guidance "addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development,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

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...

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...

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...

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 ...

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...

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...

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,...

In a report to the Department of Health and Human Services (HHS) published on Thursday, the Government Accountability Office (GAO) outlines five priorities for the US Food and Drug Administration (FDA) to address to meet its public health mission.   In the report, addressed to HHS Secretary Xavier Becerra, GAO calls for Becerra’s personal attention in addressing 61 open priority recommendations for the department and its sub agencies, 43 of which are holdovers from las...

The US Food and Drug Administration (FDA) on 17 May revised its question-and-answer guidance on inspections during the COVID-19 pandemic to clarify the regulatory actions it plans to take when it cannot conduct an onsite inspection of a facility.   FDA announced that while the pandemic continues to restrict onsite inspections, the agency “intends to continue using alternative tools to evaluate facilities.” FDA continues to conduct onsite inspections for those products ...