European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

Management 76

Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 76

European Pharmaceutical Review

NOVEMBER 8, 2022

In the US, members of the public can request, through a Citizen Petition, that the US Food and Drug Administration (FDA) “take or refrain from taking” various administrative actions, including denying approval of generic and biosimilar drug applications.

Food and Drug Administration 52

Food and Drug Administration Pharma Prescription Manufacturing 52

European Pharmaceutical Review

DECEMBER 21, 2022

The healthcare industry is successful in innovating new treatment paradigms ranging from small molecular to biological therapeutics to personalised medicines. Defossilization of pharmaceutical manufacturing. Mapping Global Flows of Chemicals: From Fossil Fuel Feedstocks to Chemical Products. 33, February 2022, 100586.

Manufacturing 74

Manufacturing Pharmaceutical Healthcare Healthcare 74