Round-up, week 16 – 20 December 2019

Round-up, week 16-20 December 2019 By Tessa Fiorini-Cohen, Stephanie Allampalli and Marthese Mifsud   Pharmtech series of articles on Pharmacopoeia Compliance 16 December 2019 Pharmtech has published a  series of articles on Pharmacopoeia Compliance. The articles include: Why Pharmacopoeia Compliance Is Necessary Why Pharmacopoeia Compliance Is Difficult A Brief History of Pharmacopoeias: A Global Perspective […]

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keyboard and monitors

Last week’s round-up, 28 October 2019 – 01 November 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   OGD Explains How it Reviews and Conducts Pre-ANDA Meetings 01 November 2019 The FDA’s Office of Generic Drugs (OGD) has explained how it evaluates and conducts meetings under its pre-abbreviated new drug application (ANDA) program. To this end, the OGD has issued a manual of policies and procedures, […]

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