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I always enjoy the conferences put on by the FDA: https://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2022-06062022 FDA Clinical Investigator Training Course (CITC) 2022 December 7 – 8, 2022 https://sbiaevents.com/citc2022/#files ------------------------------ ...

A former client of mine is looking for contractors to work on NDA and/or BLA submissions, from overall regulatory strategy to clinical studies to required documentation to NDA and/or BLA submission.  They have an IND in place, with a product classified by the FDA as a drug & biologic.  Please connect ...

Hi Shirley, I appreciate the perspective, and it sounds like Health Canada is moving in the right direction.  The timelines I obtained were back in Dec 2021 and we had cc'd the AO.  I've provided a snippet of the Health Canada response below: "I understand but please understand as per the Medical ...

The short of it is that TUV SUD issued the updated cert 4 days after expiration.  We lived with a planned deviation (and much anxiety) for those days, and had made plans to issue a product recall when Health Canada suspended the MDL. The process with Health Canada for expired MDSAP certs is as follows: ...

One of the companies I work for is struggling to obtain an updated QMS certificate from TUV SUD Americas Inc. and I'm wondering if anybody has experienced a similar issue.  At TUV SUD's delay to issue an updated QMS certificate, Health Canada is threatening to suspend my client's medical device device ...