In this week’s news, the FDA cites remote inspections as key, GAO questions efficacy of antimicrobials pathway and more.
US FDA beats target for conducting delayed facility inspections
The US FDA conducted more than double the number of domestic facility inspections it expected to in the second half of the year according to new analysts.
The regulator published its inspection figures in a report this week, explaining that initially it expected to be able to carry out 14% of the 15,000 or so audits postponed as a result of the COVID-19 pandemic.
However, in the report it said that as of September 30 it “has exceeded the Base-Case Scenario projections for FY21, completing more than twice as many domestic surveillance oversight activities than projected.”
The agency said “new oversight approaches and expanded use of a variety of surveillance tools significantly contributed” to its ability to exceed these goals.
US FDA antimicrobials pathway only resulted in two approvals since 2016
The US GAO says a regulatory pathway designed to encourage development of antimicrobials has resulted in just two approvals.
According to a new reportthe pathway – the limited population pathway for antibacterial and antifungal drugs (LPAD) – “does not address the economic challenges facing the development of these products.”
The GAO said the HHS should develop a strategy to spur the development of new treatments for antibiotic-resistant infections that uses post-market financial incentives instead.
Also in the news
The Washington Post reported that the US Government plans to invest billions to add coronavirus vaccine manufacturing capacity.
The Pink Sheet looked at how the US FDA honed its use of remote monitoring tools to “inspect” drug manufacturing facilities during the early stages of the pandemic.
A former steel mill in Pittsburgh is to become a biopharmaceutical manufacturing plant according to the Wall StreetJournal.
Fierce Pharma looked at Chinese API suppliers Zhejiang Huahai Pharmaceutical’s efforts to bring its production operations up to code after criticism by the US FDA. The agency recently published the warning letterit sent the firm in 2018.
Biomagnetic Solutions has signed a lease with GLP Development to build a cGMP-grade production facility in Innovation Park at Penn State University.
The Hill reported that several biomanufacturing companies have been hit by hackers.
Some developments of note in the contracting sector:
Metrics Contract Services’ facility in Greenville, North Carolina has successfully completed an inspection by the Brazilian National Health Surveillance Agency (ANVISA).
Biovectra announced plans for an mRNA vaccine and therapeutics production facility in Charlottetown, Canada.
WuXi Advanced Therapieshas opened an advanced therapies testing facility in Philadelphia, US citing demand from customers in cell and gene therapy industry.
Arranta Bio has sold its process development and GMP clinical manufacturing site in Gainesville, Florida, to Inceptor Bio. The firm said it will transfer client programs and key technical employees to its facility in Watertown, Massachusetts.