Monthly Archives: November 2019

//November

WEEKLY SCAN | November 10, 2019

Not much in the way of guidance this week but a busy, busy week on the warning letter enforcement front.  We provide one warning letter to a compounding pharmacy, one to an API manufacturer, and three to drug product manufacturers. For those who use recovered solvents in their manufacturing process they would be well served to read FDA’s recommendations [...]

By |2019-11-19T12:22:22+00:00November 18th, 2019|Weekly Scans|

WEEKLY SCAN | November 17, 2019

This was a busy week.  FDA published four guidance documents, Europe published one and the JP published a draft for comment. Enforcement was again busy in both the US and worldwide.  WHO published seven reports of inspections including one conducted for a bioequivalence study.  Europe published four reports of GMP non-compliance; one company had two sites inspected on the [...]

By |2019-11-26T14:35:54+00:00November 17th, 2019|Weekly Scans|

WEEKLY SCAN | November 3, 2019

Very limited on guidance again this week.  The non-guidance includes some interesting information from FDA, EMA, MHRA and one from PMDA. Enforcement included one warning letter, a handful of recalls and a form 483 that is associated with a warning letter that will likely be published in a week or two.  WHO published five inspection reports, and the EDQM [...]

By |2019-11-12T12:28:02+00:00November 12th, 2019|Weekly Scans|

MONTHLY SCAN | October, 2019

Happy Reading, Barbara FDA: DEVICES: The FR announced availability of a final guidance ‘Investigational In Vitro Diagnostics in Oncology Trials:  Streamlined Submission Process for Study Risk Determination.’ DEVICE: The FR announced availability of a guidance, ‘Type V Drug Master Files for Center for Drug Evaluation and Research Led Combination Products Using Device Constituent Parts with Electronics or Software.’ [...]

By |2019-11-07T14:51:54+00:00November 7th, 2019|Monthly Scans|

WEEKLY SCAN | October 27, 2019

Among the new guidance posted this week is a draft on data integrity from WHO. It sadly does not represent an improvement over the 2016 effective version in my opinion.  Two ICH guidance reached step 2b.  FDA published two documents, one from CDRH and one regarding IND safety reporting.  The non-guidance publications include a blog from the MHRA inspectorate, [...]

By |2019-11-05T12:54:28+00:00November 5th, 2019|Weekly Scans|