Month: December 2018

eCTD, eCTD 4, FDA, IDMP, Medical Devices

2019 FDA Goals: A Christmas Wish List

Image Credit Angie Chapman https://www.flickr.com/photos/angiet-cakefiend/7178335187/in/photolist-bWjQXM-5Nzjum-5Nvcrt-5MeAEL-2ixWd-5NvaLF-CZcM4n-7YXyHM-5eEVdZ-5eEVe6-VRZQJ5-97o4ku-FW4xX-64CNCY-X6HEUo-J3XeKS-5DgNxm-gBhhE5-X6HJ3N-7gZ4bC-5DgMhq-6khfTX-e9C6ZZ-5DcxDx-9HBaiw-nBqP7w-qBzhoK-hJYfj5-aoQA8J-iRdUdr-WTnycN-8UrP3g-7giMG1-XFeizH-8V8zy8-K6Azn-ZatFom-6z6eQG-8aNvz2-79G6Dg-XU8uhv-WntgLm-5LLfFN-SJLA7d-SKt1sH-K6kTf-QQfE51-Ujfch7-asm29b-ei5nx9

RAPS Regulatory Focus reported from the December 11, 2018 CMS/FDA Summit in Washington DC, as to Janet Woodcock’s goals for FDA in 2019. There was a focus on health, opioids, supply chain safety… all the stuff for which we all need the agency to excel, but I’m here for the changes in regulatory approval processes, …