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...

New drug shortages in the US decreased in 2020, in part because of the US Food and Drug Administration’s (FDA’s) use of enforcement discretion to ensure an uninterrupted supply of critical medical products during the COVID-19 public health crisis.   Yet, the agency’s new drug shortages report to Congress said that while these actions helped avert shortages in the short-term, more work is needed to improve supply chain resiliency.   This report summarizes the agency...

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...

The European Medicines Agency (EMA) on Thursday opened a public consultation on the International Council for Harmonisation’s (ICH) S12 guideline on nonclinical biodistribution (BD) considerations for gene therapies.   The S12 guideline recently reached Step 2b of the ICH process after being endorsed at the ICH Assembly virtual meeting earlier this month. (RELATED: ICH reports ‘significant milestones’ reached on guidelines ranging from impurity testing to eCTD standa...

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 ...

Regulators from the US Food and Drug Administration and the European Medicines Agency gave an update on desktop and virtual inspections and offered some advice on ensuring smoother audits at a 28 April webinar.   While there seemed to be acceptance among regulators that virtual and desktop inspections are a reality until the COVID-19 public health emergency is over, a larger group of health officials at the webinar said that onsite inspections are much better at uncove...

More than a year after the COVID-19 pandemic forced the US Food and Drug Administration (FDA) to halt most on-site inspections, the agency on Wednesday issued guidance detailing its approach to remote interactive evaluations of drug and biomedical research facilities during the public health emergency.   Teleconferencing, livestreaming video and screen-sharing technologies are among the tools FDA says it will use when it determines that a remote interactive evaluation ...

In closing a whistleblower case concerning allegations of downgraded inspection findings raised by a former investigator on the US Food and Drug Administration’s (FDA) Team Biologics, US Special Counsel Henry Kerner wrote to President Joe Biden that he is “troubled” by many aspects of the case.   In the letter, Kerner says that FDA’s report on its investigation of the allegations “meets all the statutory requirements but that the findings do not appear reasonable” and ...