Particulates, sterility failures and basic GMP noncompliance loomed large in FDA warning letters and EU GMP noncompliance notices to Facta Farmaceutici, Porton Biopharma, Antibioticos do Brasil, Euro Far, Ningbo Zhixin Bird Clean-Care, CTX Lifesciences and Pharmco Laboratories posted online last month.
FDA Jan. 13 gave Facta Farmaceutici SpA of Milan, Italy, a warning letter with lots of homework as a result of data integrity issues identified during an inspection a year earlier at the company’s plant in San Nicolò A Tordino, Italy.
During the inspection, FDA found an unofficial, uncontrolled spreadsheet of visible particle data that indicated multiple lots of sterile drug...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
