/Barbara W. Unger

About Barbara W. Unger

Barb is the Editor in Chief of the GMP Regulatory Intelligence Newsletter. Go to our About page to read more.

WEEKLY SCAN | June 10, 2019

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 [...]

By |2019-06-18T11:29:20+00:00June 17th, 2019|Weekly Scans|

WEEKLY SCAN | June 3, 2019

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 [...]

By |2019-06-11T12:25:20+00:00June 10th, 2019|Weekly Scans|

MONTHLY SCAN | May, 2019

Happy Reading, Barbara FDA: SUNSCREENS: The FR announced availability of a draft guidance ‘Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-counter monograph:  Study Elements and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 [...]

By |2019-06-06T20:37:00+00:00June 6th, 2019|Monthly Scans|

WEEKLY SCAN | May 26, 2019

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. [...]

By |2019-06-04T16:38:41+00:00June 4th, 2019|Weekly Scans|

WEEKLY SCAN | May 19, 2019

Just a few guidance documents this week from FDA, none from EMA, and three from WHO, one from Health Canada.  The usual collection of non-guidance documents includes a summary of 2018 GCP shortcomings identified during MHRA inspections. Enforcement includes two consent decree agreements with compounding pharmacies, notably one of which is PharMEDium. This week saw a few import alerts [...]

By |2019-05-28T11:05:39+00:00May 28th, 2019|Weekly Scans|

WEEKLY SCAN | May 13, 2019

This week saw a few guidance documents, three from FDA and one from WHO.  Nothing from Europe in the areas we follow.  The non-guidance group has the usual collection from FDA, EMA, MHRA and HPRA. Some interesting reading in the collection. Enforcement included five warning letters to either homeopathic or OTC firms continuing the FDA’s focus in this area [...]

By |2019-05-21T13:37:35+00:00May 21st, 2019|Weekly Scans|

WEEKLY SCAN | May 5, 2019

We provide a big handful of guidance in the device area from the FDA this week a couple regarding generics and wrap it up with one on sunscreen.   Nothing from the EMA but several from TGA, Health Canada, ICH and HPRA.  A busy weekend of reading.  The non-guidance publications include a blog from the MHRA inspectorate along with others [...]

By |2019-05-14T10:39:46+00:00May 14th, 2019|Weekly Scans|

MONTHLY SCAN | April, 2019

Happy Reading, Barbara FDA: OTC: FDA issued the 62-page final rule on safety and effectiveness of consumer hand sanitizers. DEVICES: The FR announced availability of a draft guidance ‘Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol’  This represent FDA’s ongoing effort to evaluate materials in medical devices for potential safety issues. DEVICE ADMINISTRATIVE: The FR announced [...]

By |2019-05-09T11:16:40+00:00May 8th, 2019|Monthly Scans|

WEEKLY SCAN | April 28, 2019

Just a couple of guidance documents this week including one from CDSCO and one from Health Canada.  We see the usual collection of non-guidance publications with more than usual from the EMA. For those of you who noticed the FDA has re-done their website and likely some of your links are broken, here’s a perspective on the new site [...]

By |2019-05-07T11:26:27+00:00May 6th, 2019|Weekly Scans|

WEEKLY SCAN | April 21, 2019

FDA published a collection of guidance, though no other authorities published the type of guidance we follow.  There is an unusually small group of non-guidance publications, perhaps the holiday week had an impact here.  Under the FDA heading for non-guidance please find the USTR Annual Special 301 Report on Intellectual Property and Review of Notorious Markets for Piracy and [...]

By |2019-04-30T11:23:39+00:00April 30th, 2019|Weekly Scans|