EMA Guidance, Recommendation paper on decentralised elements in clinical trials, 12/22 Anastasija Eschricht2023-02-24T09:09:11+00:00February 24th, 2023|
MDCG 2022 20 Substantial modification of performance study under Regulation (EU) 2017/746, 12/22 Anastasija Eschricht2023-02-24T08:57:56+00:00February 24th, 2023|
MDCG 2022 19 Performance study application/notification documents under Regulation (EU) 2017/746, 12/22 Anastasija Eschricht2023-02-24T08:52:19+00:00February 24th, 2023|
FDA GFI, Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe, 12/22 Anastasija Eschricht2023-02-24T08:47:55+00:00February 24th, 2023|
FDA GFI, SVP Drugs and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations, 12/22 Anastasija Eschricht2023-02-24T08:45:50+00:00February 24th, 2023|
EMA Guideline Start of shelf-life of the finished dosage form, 05/01 Anastasija Eschricht2022-12-07T10:51:35+00:00December 7th, 2022|