European Pharmaceutical Review

NOVEMBER 8, 2022

Pharmaceutical manufacturers have submitted Citizen Petitions raising safety or efficacy concerns about proposed competing generic and biosimilar products, and such submissions often delay FDA approval of the proposed products while the FDA resolves the pending petitions.

Food and Drug Administration 52

Food and Drug Administration Pharma Prescription Manufacturing 52

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 74

Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 74

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. The healthcare industry is successful in innovating new treatment paradigms ranging from small molecular to biological therapeutics to personalised medicines.

Manufacturing 73

Manufacturing Pharmaceutical Healthcare Healthcare 73