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20 August 2019
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research earlier this month sent a warning letter to China-based sunscreen and OTC drug manufacturer NingBo Huize Commodity Co. after the company’s general manager and qual...

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20 August 2019
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
20 August 2019
The European Commission (EC) on Tuesday added Milan, Italy-based IMQ Istituto to its list of notified bodies (NBs) designated under the new Medical Devices Regulation (MDR).
19 August 2019
The United States Pharmacopeia and National Formulary (USP-NF) last week launched a three-month public consultation on a proposal to change how impurity reporting thresholds for drug product and drug substance monographs are handled.
19 August 2019
The US Food and Drug Administration (FDA) warned Turkish drugmaker Deva Holding AS earlier this month over good manufacturing practice (GMP) violations at the company’s Tekirdağ manufacturing site.
19 August 2019
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday said it will conduct a small pilot project to test the processing and analysis of nonclinical study data provided electronically using an updated ...
19 August 2019
Beginning Monday, prospective applicants can submit pre-assigned number requests for four additional application types: new drug application (NDA), investigational new drug (IND) application, biologic license application (BLA) and drug master file...