The US FDA will let device firms modify their technology without submitting a premarket approval (PMA), a humanitarian device exemption (HDE) supplement or a 30-day notice during the covid-19 pandemic.
The agency relaxed the rules this week, explaining the aim is to give device makers flexibility to address supply chain issues resulting from shortages or facility closures.
The FDA said, “Numerous manufacturers may need to make immediate changes such as adjusting manufacturing processes to allow for social distancing, adapting their manufacturing or design due to supply chain disruption, or to moving device production to a region that is less impacted by COVID-19.”
Nipro to increase capacity at packing plants on both side of the Atlantic
Nipro Pharma Packaging will spend $60 million to increase capacity at its glass tube-draw facilities in France and the US.
According to Nipro first production is scheduled to start in 2021 with the remainder of the expansion due to complete by 2024. The firm said it will hire an additional 70 employees.
Also in the news
BARDA has granted Phlow a $354m contract to manufacture precursor chemicals for APIs in drugs used to treat patients hospitalized with Covid-19.
US industry group PhRMA says the global nature of pharmaceutical supply chains is positive for patients and drug makers.
Senator Gary Peters introduced bills to address vulnerabilities in the medical supply chain and increase capacity for domestic advanced manufacturing of critical drugs and medical devices in the US.
AgencyIQ predicts the US FDA will make greater use of quality metrics as a result of travel restrictions caused by the Covid-19 pandemic.
Pharmajet will supply Abnova with needle free injection technology for a SARS-CoV-2 vaccine it is developing. See press release.
Some developments of note in the contracting sector.
PCI Pharma plans to build a packaging facility at site in Tredegar, Wales according to the South Wales Argus.
The US has contracted Thermo Fisher Scientific to supply viral transport media (VTM) for COVID-19 sample collection. See press release.
Catalent has bought a clinical trial supply facility in Japan.