/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 | August 11, 2019

A light week for new guidance. FDA published two and that was it!  We have the usual complement of non-guidance publications from the MHRA, EMA, FDA and one from China. In the enforcement area we cover three drug warning letters, one issued to a compounding pharmacy, one device warning letter and one in the food area that is a [...]

By |2019-08-20T19:12:50+00:00August 20th, 2019|Weekly Scans|

WEEKLY SCAN | August 4, 2019

A light week for guidance with two from FDA and none from EMA.  Health Canada published two and IMDRF published one.  We have the usual collection of non-guidance publication including MHRA Inspectorate blog posts. Very light on the warning letter front this week with only one warning letter and that was issued to yet another OTC firm, continuing the [...]

By |2019-08-20T14:50:43+00:00August 12th, 2019|Weekly Scans|

MONTHLY SCAN | July, 2019

Happy Reading, Barbara SAFETY: The FR announced the availability of a final guidance, ‘Risk Evaluation and Mitigation Strategies:  Modifications and Revisions.  In conjunction with this final guidance is a revision to 1, ‘Risk Evaluation and Mitigation Strategies Modifications and Revisions.’ ADMINISTRATIVE: The FR announced that FDA is withdrawing approval of 31 ANDAs held by Apotex, a generic firm [...]

By |2019-08-08T12:11:29+00:00August 8th, 2019|Monthly Scans|

WEEKLY SCAN | July 28, 2019

Lots of new FDA guidance published this week, both draft and final.  The Federal Register  published user fees for devices, biosimilars, drugs and outsourcing facilities and these are included here.  We also provide guidance from Health Canada (2), WHO, CDSCO and China.  We have the usual collection of non-guidance publications from EMA, MHRA, FDA, HPRA, PMDA and China. This [...]

By |2019-08-06T12:40:24+00:00August 6th, 2019|Weekly Scans|

WEEKLY SCAN | July 21, 2019

FDA posted one final guidance, an important one on post approval safety reporting for combination products.  EMA had none but Health Canada, France, WHO, TGA and CDSCO each had one. In the enforcement section, note a CRL issued for problems with the manufacturer of the API used in a bioequivalence study.   This is different from the API manufacturer of [...]

By |2019-07-30T12:37:57+00:00July 30th, 2019|Weekly Scans|

WEEKLY SCAN | July 14, 2019

This week has a complement of guidance from the FDA, EMA, IMDRF, ANVISA and TGA.  Everyone is busy.  We have a smaller than usual group of non-guidance documents from EMA, FDA, HPRA and MRA. In enforcement, the FDA published three drug warning letters this week, one of which was issued in April.  The warning letter to Strides Pharma Science [...]

By |2019-07-23T13:33:07+00:00July 23rd, 2019|Weekly Scans|

WEEKLY SCAN | July 7, 2019

Among the most important announcements this week is that the FDA and EMA Mutual Recognition Agreement is now fully active.  This has been in the works, in many iterations for a long time!  One of the benefits will be that’s firms do not need to retest covered products upon their shipment from the US to EU countries!  In the [...]

By |2019-07-16T13:00:33+00:00July 16th, 2019|Weekly Scans|

MONTHLY SCAN | June, 2019

Happy Reading, Barbara FDA: CLINICAL: The FR published availability of a draft guidance ‘Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs’ CLINICAL: The FR announced the availability of a draft guidance ‘Treatment for Heart Failure:  Endpoints for Drug Development.’  FDA is hoping this will spur the development of new treatments for [...]

By |2019-07-12T04:20:26+00:00July 12th, 2019|Monthly Scans|

WEEKLY SCAN | June 23, 2019

After a few slow weeks, this was a busy one for guidance and a proposed rule publication from FDA.  Among the group, two are ICH guidance available for comment, and one is a proposed rule implementing features of the BPCI Act of 2009.  The EMA published clinical guidance and an Aide Memoire addressing inspection of safety features required by [...]

By |2019-07-02T18:19:21+00:00July 2nd, 2019|Weekly Scans|

WEEKLY SCAN | June 17, 2019

Just a small handful of guidance published this week, two from FDA and one each from EMA and TGA.  We have the usual collection of non-guidance documents from MHRA, EMA, and FDA. Warning letter enforcement is sparse this week with only one drug GMP warning letter, none to compounding pharmacies and none to device firms.  We also provide a [...]

By |2019-06-25T14:01:52+00:00June 25th, 2019|Weekly Scans|