/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 | February 17, 2019

A busy week for both guidance and enforcement, a full weekend full of reading. A variety of guidance and proposed rule from the FDA this week, a draft guideline on clinical trials from the EMA and a draft guidance from WHO on production of WFI by processes other than distillation. From the FDA we have two modified guidance regarding [...]

By |2019-02-26T20:06:45+00:00February 26th, 2019|Weekly Scans|

WEEKLY SCAN | February 10, 2019

Another busy week on the guidance publication front for FDA.  Several for devices and quality, then one each for generics and a final rule for bulk drug substances for compounding. A busy week for all.  We provide the usual collection of non-guidance documents from EMA, FDA, MHRA and one from HPRA. Enforcement this week includes an interesting first-of-kind warning [...]

By |2019-02-19T15:46:04+00:00February 18th, 2019|Weekly Scans|

WEEKLY SCAN | February 3, 2019

Seems we are back to normal with FDA back up and in business with five publications this week.  Two addressed devices, two focused on safety one on combination products and one was administrative. ICH and WHO each published one and HPRA published two documents. Enforcement was back in full swing with three drug GMP warning letters this week.  Once [...]

By |2019-02-12T12:45:34+00:00February 11th, 2019|Weekly Scans|

MONTHLY SCAN | January, 2019

We started the first full week of the new year with a special supplement that provides an analysis of FY2018 drug warning letters.  It provides an analysis of the type of manufacturers who received drug warning letters,  the country in which they are located, interval between inspection and warning letter and import alert, and trends in areas of enforcement [...]

By |2019-02-08T12:30:45+00:00February 7th, 2019|Monthly Scans|

WEEKLY SCAN | January 27, 2019

Almost back to normal on the FDA publication front.  Three documents, along with two from the EMA, along with Swiss Medic.  There is also the full complement of non-guidance publications from MHRA, EMA/EC, FDA, and HPRA.  Lots of reading. Enforcement included two warning letters. One was sent to an OTC manufacturer in China, and other to an infertility clinic [...]

By |2019-02-05T12:45:42+00:00February 4th, 2019|Weekly Scans|

WEEKLY SCAN | January 20, 2019

This is another slow week with the ongoing partial US government shut down.  FDA published four guidance this week but these were not published in the Federal Register as is the usual requirement and practice.  Look for these to show up when everyone goes back to work and digs out from the collection of activities that accumulated during the [...]

By |2019-01-30T18:21:25+00:00January 28th, 2019|Weekly Scans|

WEEKLY SCAN | January 13, 2019

Another slow week for FDA actions due to the partial government shutdown.  No import alerts in the areas we cover, one draft guidance in the generics area though we don’t have the Federal Register publication yet. PIC/S, HPRA, and TGA had guidance published.  A few recalls including a couple in the Class I category. One European report of GMP [...]

By |2019-01-23T01:53:37+00:00January 21st, 2019|Weekly Scans|

WEEKLY SCAN | January 6, 2019

The FDA is still mostly furloughed except for safety issues.  Others are back on a more normal post-holiday work effort. Nothing from the EMA or FDA in terms of guidance but a handful from TGA. Non-guidance items include those from MHRA, EMA, FDA, ICH and HPRA.  We provide one warning letter issued to the Akorn Inc facility in Decatur [...]

By |2019-01-15T19:45:07+00:00January 15th, 2019|Weekly Scans|

MONTHLY SCAN | December, 2018

Happy reading! Barbara FDA: DRUG: The FR announced availability of the final FDA guidance “Data Integrity and Compliance with Drug GMPs” PHARMACIES: The FR announced availability of a draft guidance ‘Current Good Manufacturing Practice – Guidance for human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act’ ADMINISTRATIVE: The FR published a proposed rule regarding the [...]

By |2019-01-11T15:00:23+00:00January 11th, 2019|Monthly Scans|