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CDER Seeks Manufacturers for Quality Benchmark Study

The Center for Drug Research and Evaluation (CDER) is inviting drugmakers to take part in a study of pharmaceutical quality management systems.



The agency aims to find the attributes of effective quality systems for use in developing a quality benchmark.



The study is being conducted by Dun & Bradstreet and the University of St. Gallen in Switzerland. It will begin this month and end in December. 



[FDANews]

03

Lug

Generici e biosimilari. Presentato alle Istituzioni il “Manifesto per la ripartenza”

Una nuova politica industriale che garantisca sostenibilità al comparto pharma, assicurando a tutte le sue componenti regole chiare, certe e semplificate e ridia maggiore autonomia e capacità...

30

Giu

The COVID-19 Pandemic Sheds Light on the Over-Reliance on Offshore Drug Manufacturers

Four ideas to bring drug substance and drug product manufacturing back to the U.S....[ContractPharma]

30

Giu

Active Pharmaceutical Ingredients: How dependent is India on China

Despite calls to reduce imports from China, India's reliance on its hostile neighbour for the pharmaceutical sector remains. At least 60% of India's Active Pharmaceutical Ingredient (API) requirements...

26

Giu

EMA nominates executive director to replace Rasi

The European Medicines Agency’s (EMA) Management Board on Thursday nominated Emer Cooke from a short list of candidates to succeed Guido Rasi as the agency’s next executive director...[EMA]

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