/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 | December 30, 2018

Another short week with the New Year’s holiday, and the partial US government shutdown that impacts non-essential FDA activities. We have included a Special Report that can be downloaded in pdf on the Criteria for Drug Inspections. Hopefully a bit more back to normal next week! Happy Reading, Barbara FDA: none this week EMA: none this week  OTHER: [...]

By |2019-01-08T19:59:31+00:00January 8th, 2019|Weekly Scans|

WEEKLY SCAN | December 23, 2018

A very light holiday week, and the partial government shut down also took its toll on publications.  Next week with the new years holiday will likely be similar.  This week was essentially limited to recalls and import alerts. Happy Reading, Barbara FDA: none this week EMA: none this week  OTHER: none this week MHRA published the following/updates: [...]

By |2019-01-01T17:57:47+00:00January 1st, 2019|Weekly Scans|

WEEKLY SCAN | December 16, 2018

Both FDA and EMA published two guidance documents this week.  There is the usual collection of non-guidance documents from MHRA, FDA, EMA, and HRPA and Health Canada this week. Enforcement was a bit light on warning letters.  One to a drug manufacturer and a scathing one to a firm manufacturing human cell and tissue derived products.  This one identifies [...]

By |2018-12-26T04:55:46+00:00December 26th, 2018|Weekly Scans|

WEEKLY SCAN | December 9, 2018

A busy week on the guidance front from the FDA.  At long last the final Data Integrity Guidance Q&As published.  The draft guidance on GMPs for Outsourcing Facilities also was made available for comment.  A handful of biosimilar guidance published, some draft, some final. And finally, a couple of administrative documents were made available. A final guidance on site [...]

By |2018-12-18T11:47:38+00:00December 18th, 2018|Weekly Scans|

WEEKLY SCAN | December 2, 2018

A light week for guidance documents, the FDA published one device guidance, one proposed rule, and a final guidance for generic drug manufacturers.  The EMA didn’t publish anything in the areas we routinely cover.  The HPRA published new guidance for wholesale distributors. Among the non-guidance documents released this week, MHRA published a couple of pharmacovigilance metric summaries, EMA published [...]

By |2018-12-11T11:38:52+00:00December 10th, 2018|Weekly Scans|

MONTHLY SCAN | November, 2018

Happy reading! Barbara FDA: GENERAL: The FR announced that FDA is opening a public document regarding Prescription Drug-Use-Related Software DEVICES: The FR announced the publication of premarket approval applications and humanitarian device exemption applications that have been approved. DEVICES: The FR announced availability of a final guidance that is immediately effective, ‘Unique device Identification: Policy Regarding Compliance Dates [...]

By |2018-12-06T14:59:13+00:00December 6th, 2018|Monthly Scans|

WEEKLY SCAN | November 25, 2018

Happy Reading, Barbara FDA: DEVICES: The FR announced availability of a draft guidance ‘Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies’. DRUGS: The FR announced availability of draft and revised Product-Specific Guidance. DRUGS: The FDA released MAPP 4190.1 Rev 3, Drug Shortage Management EMA: SAFETY: Reflection paper on the qualification of non-genotoxic impurities  [...]

By |2018-12-04T12:52:53+00:00December 3rd, 2018|Weekly Scans|

WEEKLY SCAN | November 18, 2018

I was all ready to explain away a short newsletter based on the long Thanksgiving holiday weekend in the US.  But no, this is a long one, with lots of warning letter action and an EU report of GMP non-compliance.  Four drug warning letters, including one to Mylan’s Morgantown WV site, and one to a device manufacturer were posted [...]

By |2018-11-27T14:59:14+00:00November 27th, 2018|Weekly Scans|

WEEKLY SCAN | November 11, 2018

This week has one guidance from FDA and two from EMA.  The one addressing pharmaceutical water quality is important for everyone to read, even though it is a draft.  IMDRF published three final documents, HPRA and New Zealand each published one.  We saw the usual collection of non-guidance documents from FDA, MHRA, EMA and others. FDA published one device [...]

By |2018-11-20T14:21:42+00:00November 19th, 2018|Weekly Scans|

WEEKLY SCAN | November 4, 2018

From the fire area of Thousand Oaks CA, the firefighters are loved here and with good reason!  Truly exceptional people to whom we owe our gratitude. A few guidance documents from FDA, EMA and CDSCO.  Some good reading.   The usual group of non-guidance from the FDA, EMA, MHRA, HPRA and TGA this week. Enforcement again this week is slow [...]

By |2018-11-13T19:39:45+00:00November 13th, 2018|Weekly Scans|
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