Monthly Archives: May 2019

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|

Analysis Of CY2018 FDA Warning Letters That Cite Data Integrity Failures

An evaluation of warning letters associated with data governance and data integrity deficiencies. In this summary, we identify: • CY2018 warning letters that cite data integrity deficiencies • The number of warning letters citing this topic in the past 11 years and the countries where these sites are located • The regulations identified most frequently in CY2018 drug GMP [...]

By |2019-07-30T18:19:56+00:00May 22nd, 2019|Special Reports|

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 DEVICES: The FR announced availability of a draft guidance ‘Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol’  This represent FDA’s ongoing effort to evaluate materials in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|