Just a small handful of guidance published this week, two from FDA and one each from EMA and TGA. We have the usual collection of non-guidance documents from MHRA, EMA, and FDA. Warning letter enforcement is sparse this week with only one drug GMP warning letter, none to compounding pharmacies and none to device firms. We also provide a [...]
We had an unusually busy week of enforcement with seven drug GMP warning letters and one device warning letter. We have two forms 483 from recent inspections of firms in India, one 15 pages long, the other 23 pages long. Both of these forms 483 have data integrity deficiencies and are worth reading in their totality. Nothing novel in [...]
Just a couple of guidance documents this week, one from the FDA and two from EMA. We also have the usual collection of non-guidance publications from US, EU, MHRA and HPRA. A slow warning letter week with just two new letters published. Recalls and import alerts were identified. Nothing from Europe regarding GMDP inspections. Several articles are provided in [...]
Happy Reading, Barbara FDA: SUNSCREENS: The FR announced availability of a draft guidance ‘Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-counter monograph: Study Elements and Considerations. Additional information is provided by an FDA In Brief Article GENERICS and BIOSIMS: The FR announced availability of a final guidance, ‘Considerations in Demonstrating Interchangeability [...]
This was a holiday week in the US, and may explain the shortage of published items, at least from the FDA. Guidance seems to be skipping this week. There was, however, the usual group of non-guidance documents. Enforcement saw a single untitled letter to a stem cell facility (and 50-plus affiliates) and a warning letter to a compounding pharmacy. [...]