Barb

/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 | April 14, 2019

A handful of guidance this week from FDA, EMA and Health Canada.  We provide the usual collection of non-guidance publications from the EMA, FDA, MHRA, HPRA, WHO and the Netherlands MEB. Enforcement included two drug warning letters to pharma firms, and one to a compounding pharmacy.  This rounded out with a collection of recalls and import alerts.  Nothing from [...]

By |2019-04-23T11:23:32+00:00April 20th, 2019|Weekly Scans|

WEEKLY SCAN | April 7, 2019

One final rule from FDA and a variety of updated items from the EMA, three items from WHO and one from Canada.  A collection of reading for the week.   We have the usual collection of non-guidance items from FDA, EMA, MHRA, HPRA. Enforcement was a bit slow with no drug or device GMP warning letters except for two issued [...]

By |2019-04-16T13:14:44+00:00April 15th, 2019|Weekly Scans|

MONTHLY SCAN | March, 2019

Happy Reading, Barbara FDA: BIOLOGICS: The FR announced availability of a draft guidance for industry ‘Nonproprietary Naming of Biological Products Update’. Commissioner Gottlieb issued a statement on naming of biological medicines to balance competition and safety for patients receiving these products. BIOLOGICS: The FDA published MAPP 6720.5 ‘Procedures for Handling Request for Nonproprietary Name Suffix Review for Biological [...]

By |2019-04-11T17:42:12+00:00April 11th, 2019|Monthly Scans|

WEEKLY SCAN | March 31, 2019

Guidance this week from FDA, EMA, IMDRF, Health Canada, WHO and TGA.  Everyone was busy.  We include the usual collection of non-guidance documents too from MHRA, EMA, FDA, TGA, Scotland, HPRA and ICH. Enforcement in terms of warning letter posting was busy this week.  A total of 7 in the pharma area and one to a CDRH in vitro [...]

By |2019-04-09T12:23:47+00:00April 6th, 2019|Weekly Scans|

WEEKLY SCAN | March 25, 2019

Several guidance were published this week including from FDA, ICH and Health Canada.  We also have the usual collection of relevant non-guidance items from FDA, EMA, MHRA, and HPRA. There were two drug GMP warning letters posted this week, and then two to compounding pharmacies.   We also include a form-483 issued to Sun Pharmaceuticals which had a single multi-part [...]

By |2019-04-02T13:48:32+00:00March 30th, 2019|Weekly Scans|

WEEKLY SCAN | March 18, 2019

A handful of guidance, two from FDA, four from MHRA and one from IMDRF.  We also include the non-guidance publications from EMA, FDA, MHRA and TGA. Regarding enforcement, this week had three device warning letters posted and one warning letter to a pharmaceutical manufacturer.  With recalls, one firm had > 450 products recalled as Class I recalls, and there [...]

By |2019-03-26T12:49:44+00:00March 26th, 2019|Weekly Scans|

WEEKLY SCAN | March 10, 2019

A broad collection of guidance from FDA, EMA, MHRA, Health Canada and TGA.  This week saw a smaller than usual collection of non-guidance documents. Warning letters posted this week include ones demonstrating FDA’s continued focus on OTC product manufacturers,  and manufacturers in India including a particularly testy letter to Pfizer for a Hospira site in India that they are [...]

By |2019-03-19T10:46:55+00:00March 19th, 2019|Weekly Scans|

WEEKLY SCAN | March 3, 2019

The big news this week is the unexpected departure of FDA Commissioner Gottlieb.  No reason is public yet, but he leaves in approximately one month.   FDA Law Blog provides a blog with a nice synopsis of his accomplishments in the two years that he served as FDA Commissioner. We have a couple of interesting guidance from FDA this week [...]

By |2019-03-12T20:09:32+00:00March 12th, 2019|Weekly Scans|

MONTHLY SCAN | February, 2019

Happy Reading, Barbara FDA: TOBACCO: The FR announced availability of a revised draft guidance ‘Use of Investigational Tobacco Products.’ TOBACCO: The FR published a draft guidance, ‘Smoking Cessation and Related Indications:  Developing Nicotine Replacement Therapy Drug Products.’ TOBACCO: The FR announced availability of the draft guidance, ‘Enforcement policy for Certain Marketed Tobacco Products’ BLOOD ESTABLISHMENTS: Exceptions and Alternative [...]

By |2019-03-07T14:09:55+00:00March 6th, 2019|Monthly Scans|

WEEKLY SCAN | February 24, 2019

Another busy week with guidance publication from both the US and Europe.  Good for reading on a rainy or cold weekend.  We have the usual collection of non-guidance documents from the EMA, FDA, MHR and HPRA.  This includes two annual reports from the FDA. Enforcement saw a few warning letters, and two forms 483 from recent inspections. The two [...]

By |2019-03-05T19:40:25+00:00March 4th, 2019|Weekly Scans|