/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 1, 2019

After a couple of busy weeks, this is a slow one for both guidance publications and enforcement.  The most interesting guidance is one from EMA on GCPs for Advanced Therapy Medicinal Products.  ICH also published ICHQ12, and PIC/S published guidance on evaluating a Pharmaceutical Quality System with regard to risk-based change management. And in the non-guidance section, WHO is [...]

By |2019-12-10T14:30:16+00:00December 10th, 2019|Weekly Scans|

MONTHLY SCAN | November, 2019

Happy Reading, Barbara FDA: DEVICES: The FR announced the availability of final guidance published ‘Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices’ .  The intent of the guidance is to provide transparency on the decision-making process for denial of a certificate and identifies how to request a review of the [...]

By |2019-12-05T15:38:04+00:00December 5th, 2019|Monthly Scans|

WEEKLY SCAN | November 24, 2019

Just a few new guidance documents, one from EMA and three from the FDA.  Probably the most interesting is the one addressing immunogenicity for biosimilar and interchangeable insulin products. On the enforcement front, EDQM has been exceptionally active in posting inspections for GMP non-compliance identified during recent inspections, perhaps reflecting the completion of the EMA move from London to [...]

By |2019-12-03T13:09:50+00:00December 3rd, 2019|Weekly Scans|

WEEKLY SCAN | November 10, 2019

Not much in the way of guidance this week but a busy, busy week on the warning letter enforcement front.  We provide one warning letter to a compounding pharmacy, one to an API manufacturer, and three to drug product manufacturers. For those who use recovered solvents in their manufacturing process they would be well served to read FDA’s recommendations [...]

By |2019-11-19T12:22:22+00:00November 18th, 2019|Weekly Scans|

WEEKLY SCAN | November 17, 2019

This was a busy week.  FDA published four guidance documents, Europe published one and the JP published a draft for comment. Enforcement was again busy in both the US and worldwide.  WHO published seven reports of inspections including one conducted for a bioequivalence study.  Europe published four reports of GMP non-compliance; one company had two sites inspected on the [...]

By |2019-11-26T14:35:54+00:00November 17th, 2019|Weekly Scans|

WEEKLY SCAN | November 3, 2019

Very limited on guidance again this week.  The non-guidance includes some interesting information from FDA, EMA, MHRA and one from PMDA. Enforcement included one warning letter, a handful of recalls and a form 483 that is associated with a warning letter that will likely be published in a week or two.  WHO published five inspection reports, and the EDQM [...]

By |2019-11-12T12:28:02+00:00November 12th, 2019|Weekly Scans|

MONTHLY SCAN | October, 2019

Happy Reading, Barbara FDA: DEVICES: The FR announced availability of a final guidance ‘Investigational In Vitro Diagnostics in Oncology Trials:  Streamlined Submission Process for Study Risk Determination.’ DEVICE: The FR announced availability of a guidance, ‘Type V Drug Master Files for Center for Drug Evaluation and Research Led Combination Products Using Device Constituent Parts with Electronics or Software.’ [...]

By |2019-11-07T14:51:54+00:00November 7th, 2019|Monthly Scans|

WEEKLY SCAN | October 27, 2019

Among the new guidance posted this week is a draft on data integrity from WHO. It sadly does not represent an improvement over the 2016 effective version in my opinion.  Two ICH guidance reached step 2b.  FDA published two documents, one from CDRH and one regarding IND safety reporting.  The non-guidance publications include a blog from the MHRA inspectorate, [...]

By |2019-11-05T12:54:28+00:00November 5th, 2019|Weekly Scans|

WEEKLY SCAN | October 20, 2019

Two of the three guidance from FDA this week address homeopathic products.  Perhaps the FDA is finally beginning their ‘modernization’ of the regulation of these products.  None too soon!  Other guidance is provided by Hong Kong, Malaysia and TGA.  We also provide the usual collection of non-guidance publications. Enforcement this week includes only two drug warning letters, one of [...]

By |2019-10-29T11:41:46+00:00October 29th, 2019|Weekly Scans|

WEEKLY SCAN | October 13, 2019

This was a light week in terms of guidance publications.  The non-guidance group however continues to be busy.  The first bullet point under the EMA in the non-guidance area regarding assessments for nitrosamines for MAHs is a must read for any firm that manufactures chemically synthesized APIs.  Section 12 of this Q&A is new and addresses the potential cause [...]

By |2019-10-22T11:57:42+00:00October 22nd, 2019|Weekly Scans|