2019, Food and Drug Administration, Healthcare and Pharmaceutical manufacturing

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2019

Food and Drug Administration

Healthcare

Pharmaceutical manufacturing

Economics and risks of FDA’s Quality management maturity rating programme

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

Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing

FDA warning letters highlight CAPA concerns

European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. In subsequent years, up to 2022, half this number or less were issued.

FDA

FDA Food and Drug Administration Media Manufacturing

Pharma Rep Focus

Economics and risks of FDA’s Quality management maturity rating programme

FDA warning letters highlight CAPA concerns

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