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 European Medicines Agency (EMA) issued a favorable opinion for bluebird bio’s Skysona (elivaldogene autotemcel), a gene therapy that treats early cerebral adrenoleukodystrophy (CALD). Seven other medicines also received positive recommendations from the agency’s Committee for Medicinal Products for Human Use (CHMP) during its May meeting.   Skysona’s status as an advanced therapy medicinal product (ATMP) means it was first assessed by EMA’s Committee for Advanced T...

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 ...

Two papers in JAMA Internal Medicine highlighted separate, but important issues concerning the US Food and Drug Administration’s authority to modify package inserts and the effect of a recently shuttered agency initiative.   In a Viewpoint, Bishal Gyawali, MD, PhD, and colleagues at the Program on Regulation, Therapeutics and Law (PORTAL) research group at Harvard Medical School and Brigham & Women’s Hospital suggested improving FDA’s authority to modify drug package...

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 ...

For decades, the Government Accountability Office (GAO) has raised concerns about the US Food and Drug Administration’s (FDA) inspections program. Now, a year after the agency halted most of its foreign and domestic inspections due to the COVID-19 pandemic, GAO warns that the ensuing backlog could take years to clear.   In a new report and testimony before the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related...

Recon:   Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US New, Daily Coronavirus Cases Drop Below 100K For First Time In Months ( NPR ) U.S. Continues To Accelerate Vaccination Strategy ( NPR ) Seven coronavirus variants potentially similar to UK type have been detected in US: study ( The Hill ) ( NYT ) Fauci Awarded $1 Million Israeli Prize For 'Speaking Truth To Power' Amid Pandemic ( NPR ) Pentago...

The US Food and Drug Administration (FDA) says it has put in place an interim process to communicate issues identified during record reviews done in lieu of or in advance of preapproval inspections with drugmakers and consider their responses before taking action on an application.   The agency says the interim process will continue throughout the COVID-19 public health emergency and may be extended to other drug inspection programs, including routine surveillance insp...