In this week’s news, US FDA encourages generics innovation, ICH updates on solvent guidelines and more…
US FDA discusses inspections during the pandemic and outline new plan
The FDA has shared details of the pandemic’s impact on inspection activities in a new report.
According to the analysis, between March 2020 and March 2021 the agency carried out eight mission-critical in-person inspections of device facilities, 10 biologics-related mission-critical inspections and just 28 of 821 overseas mission critical inspections.
The FDA wrote, “While FDA has continued many of our oversight activities, there is no doubt that the pandemic has had an impact on our inspectional work.”
The regulator also shared outlines of its “Resiliency Roadmap,” explaining it had “looked at existing oversight tools and authorities and considered ways to optimize our surveillance and weave new approaches into our oversight scheme.”
“Product specific guidance should not stifle generics sector” says FDA
In other news, the FDA has said it is open to new ways of developing generic drugs.
The agency made the comments in a webinar this week, explaining that while there are numerous product-specific guidance documents for non-branded products these should not “diminish innovation or creativity.”
FDA and EMA can introduce ICH revised solvent exposure guideline
The International Council for Harmonization’s (ICH) efforts to revise its guideline for solvent expose from drug products can now be implemented by regulators.
The revised guideline (here) includes permitted daily exposure (PDE) levels for 2-methyltetrahydrofuran (2-MTHF), cyclopentyl methyl ether (CPME) and tertiary butyl alcohol (TBA), three solvents that are widely used in drug production.
The organisation said the aim is to “recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient”. The guideline recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.
Also in the news
The Wall Street Journal examined how vaccine manufacturers are working together to ensure supplies of Covid-19 shots.
In a related announcement, Moderna has signed a deal that will see French drug maker Sanofi help it make its SARS-Cov-2 vaccine for the US market.
The Pink Sheet looked at the lengthy development process for US FDA remote inspection guidelines. Aligning the various agency functions was a major challenge according to the article.
Bioprocess Insider reported on Emergent’s efforts to reorganize its operations in light of issues relating to Covid-19 vaccine production.
A study in JAMA looked at the link between drug prices, branded medicines and generics.
Some developments of note in the contracting sector:
Vetter and Rentschler Biopharma have expanded their partnership by establishing a new framework and governance structure for how they will work on customer projects. See press release.
Gene therapy firm AavantiBio has hired Catalent to develop and manufacture its products, including its program in Friedreich’s Ataxia (FA).
In other new Catalent has teamed up with Stirling Ultracold in a deal that gives the CDMO access to the latter’s ultra-low temperature freeze technologies.