European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

FDA 91

FDA Food and Drug Administration Pharma Pharmaceutical manufacturing 91

European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. Some countries have blocked parallel trade to prevent supplies from depleting.

Pharmaceutical 94

Pharmaceutical Food and Drug Administration Transportation Manufacturing 94

Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S.

Food and Drug Administration 52

Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52

Pharmaceutical Technology

MARCH 22, 2023

During the pandemic, the shortage of basic drugs such as paracetamol in key EU countries led to growing calls to push local drug manufacturing to ensure a smooth supply and to minimise shortages. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Government Pharmaceutical 105