European Pharmaceutical Review
JANUARY 16, 2023
Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.
European Pharmaceutical Review
AUGUST 9, 2022
Burkholderia species are one of the primary causes of non-sterile pharmaceutical product recalls and accounted for 45.3 percent of recalls recorded by the US Food and Drug Administration (FDA) between 2012 and 2019. Daddy Gaoh et al.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
European Pharmaceutical Review
APRIL 8, 2025
Implementing PAT in (bio)pharmaceutical manufacturing New sensors or larger equipment with more complex setups (software and hardware) require stringent procedures to become fully implemented in a good manufacturing practice (GMP) manufacturing facility. Q10 Pharmaceutical Quality System. Boca Raton, FL: CRC Press.
FDA Law Blog: Biosimilars
APRIL 16, 2024
Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).
Express Pharma
AUGUST 13, 2024
Sustainability in the pharmaceutical sector is becoming increasingly critical. With growing awareness of the environmental impact of pharmaceutical manufacturing—such as pollution from toxic discharges—companies must adopt more sustainable practices. How can the pharma sector make sustainability more sustainable?
European Pharmaceutical Review
DECEMBER 21, 2022
2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceutical manufacturing. Defossilization of pharmaceutical manufacturing.
RX Note
NOVEMBER 15, 2023
concerns about side effects) NOTE: Pharmaceutical manufacturers tend to concentrate on behavioural factors, producing combination tablets or once-daily version of their medicines, which are supposed easier to take. simply forgetting) Intentional (voluntary) or cognitive (e.g.
Expert insights. Personalized for you.
122 
Let's personalize your content