In this week’s news, the US FDA focuses on import quality and the impact of COVID-19 on the increasing use of virtual inspections. In addition, protocol modifications have been released to minimize operational interruptions on non-COVID related clinical trials of medical products.
US FDA finds foreign manufacturers of complex drug meeting quality requirements
US FDA research suggests manufacturers of hard-to-make pharmaceuticals are achieving quality standards demanded by the regulator.
According to a study published in JAMA, the agency looked at the quality attributes of 252 immediate-release solid oral dosage forms that are considered difficult to make on the basis of product quality history.
The report concludes that, “All products were tested within their shelf life on the basis of the legally recognized tests of the US Pharmacopeia for the major quality attributes of dosage unit uniformity and dissolution. These tests measure dosage consistency and drug release, respectively.”
The finding will help address concerns about the quality of complex products made outside the US, according to the authors.
Recent reports have questioned the overall quality of the US prescription drug supply, particularly for generic drugs and international manufacturing.
They added “Some HCPs [health care professionals] have been vocally sceptical of the quality of certain drug products, seemingly using limited or anecdotal evidence.”
More UK advice for pharma and CDMOs on the end of the Brexit transition
The UK MHRA has posted another set of guidance documents to help drug firms and CDMOs navigate the end of the Brext transition period. New documents are available on the requirements for clinical trial registrations and amendments.
The MHRA also sets out its thinking on medical devices, explaining the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) will “not automatically apply in Great Britain,” because they will not come into force until after the UK leaves the EU.
The MHRA updated guidance documents pertaining to the import and export of medicines, active substances and investigational products providing advice for post-transition. New guidance also lists approved countries for importing medicines, batch testing and those with equivalent regulatory standards for active pharmaceutical ingredient (API) manufacturing.
US FDA sets out advice on nitrosamine
The US FDA has issued long awaited guidelines on nitrosamine impurities. The document explains how manufacturers can prevent carcinogenic nitrosamine impurities getting into finished drug products and active pharmaceutical ingredients.
In recent years nitrosamines have been found at elevated levels in pharmaceutical products including valsartan, the angiotensin II receptor blocker, and related drug classes.
In a press release announcing the new guidelines, FDA Commissioner Stephen Hahn said “We believe that the guidance we’ve issued today will assist manufacturers in preventing unacceptable levels of nitrosamines in drugs.”
Also in the news
U.S. Army contracts Ology Bioservices in support of Operation Warp Speed, a response to COVID-19
The US army has hired Ology Bioservices, a biologics contract development and manufacturing organization, to perform fill-finish duties for targeted COVID-19 vaccines and therapeutics.
In support of the Operation Warp Speed response to the ongoing pandemic, Ology Bioservices will be responsible for managing the production capacity of approximately 186,840,000 doses of vaccines for COVID-19. In addition to managing the production capacity for these thereputics, the CDMO is will also be involved in the fill-finish operations of the Warp Speed response as needed. The contract ceiling value is $106.3 million.
To learn more about the Warp Speed Response and Ology Bioservices, read Ology’s press release.
FDA guidance on the conduct of clinical trials during COVID-19
While the search for a COVID-19 vaccine continues, clinical trail activity has increased rapidly. This increased COVID-19 activity has affected non-COVID related trials negatively. Many clinical trials not related to the pandemic have experienced operational interruptions and delays resulting in entire trials being placed at risk.
As a result, the U.S. Food and Drug Administration (FDA) released “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” to address the need for protocol modifications during the pandemic. The guidance is intended to last only the duration of the COVID-19 pandemic and aims to provide considerations and measures to be taken regarding clinical trial integrity and safety in accordance with the current public health crisis.
STAT looked at US President Donald Trump’s efforts to influence the decision making of the FDA.
Lexology takes a look at US President Donald Trump’s efforts to encourage local manufacturing and force pharma to cut prices (must be registered).
The Pink Sheet says the Covid-19 pandemic has ushered in the age of virtual manufacturing facility inspections. See more here (subscription required).
Some developments to note in the contracting space:
AstraZeneca has expanded its agreement with Catalant. The US CDMO will prepare its facility in Harmans, Maryland to make the drug substance for the candidate vector-based COVID-19 vaccine, AZD1222. See press statement.
Investment group Kohlberg and Mubadala will buy a majority holding in PCI Pharma Services. See press release.
Epirium has hired Piramal Pharma to supply formulation development, APIs and intermediate production, chemistry development and manufacturing, and solid oral dosage form drug product services. See announcement.
Spanish regulator AEMPS cleared LSNE Contract Manufacturing to make clinical stage biotechnology-based therapeutics at its aseptic fill-finish facility in León, Spain. See press release.