European Pharmaceutical Review

OCTOBER 19, 2022

Patents are often described as the ‘lifeblood’ of pharmaceutical companies. 1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. 23 April 2013.

Food and Drug Administration 96

Food and Drug Administration Pharmaceutical products Pharmaceutical FDA 96

European Pharmaceutical Review

MARCH 11, 2024

Additionally, this can be caused by “poor handling, repackaging, and nonadherence to good manufacturing practices [GMP] during dispensing and packaging have resulted in the microbiological contamination of non-sterile pharmaceutical products.” Ahmed et al. One case of drug contamination from 2021 was highlighted in the paper.

Pharmaceutical 98

Pharmaceutical Food and Drug Administration Manufacturing Pharmaceutical products 98

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. Tony Cundell: Perhaps the second greatest challenge is the ongoing transition from products based on small molecules to large molecules to cellular therapies.

Pharmaceutical 128

Pharmaceutical Food and Drug Administration Manufacturing Medicine 128

European Pharmaceutical Review

APRIL 8, 2025

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT. Q13 Continuous Manufacturing of Drug Substances and Drug Products. Lezotre PL.

Manufacturing 52

Manufacturing Food and Drug Administration Management Pharmaceutical 52

European Pharmaceutical Review

DECEMBER 23, 2024

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. Pharmaceutics. ICH Q8(R2) Pharmaceutical Development – Scientific Guideline. ICH Guideline Q12 On Technical And Regulatory Considerations For Pharmaceutical Product Lifecycle Management. EMA/CHMP/ICH/353369/2013.

Safety 52

Safety Pharmaceutical Manufacturing Management 52