Monthly Archives: June 2018


WEEKLY SCAN | June 17, 2018

Lots of PIC/S guidance this week along with a couple each from the FDA and EMA, and one each from MHRA and HPRA.  FDA’s withdrawal of a draft biosimilar guidance is in response to industry concerns about the bar that was set in setting biosimilarity over time.  It will be interesting to see the revised draft guidance when it [...]

By |2018-06-26T18:21:16+00:00June 26th, 2018|Weekly Scans|

WEEKLY SCAN | June 10, 2018

A busy week on the guidance publication front for FDA, WHO, HPRA and Health Canada.  A busy weekend of reading material! Among the most important from the FDA is the 21-page item on alternative mechanisms for complying with the GMPs for combination products. The non-guidance area includes the usual collection from MHRA including an inspectorate blog post, FDA, EMA [...]

By |2018-06-18T22:42:08+00:00June 19th, 2018|Weekly Scans|

WEEKLY SCAN | June 3, 2018

A handful of guidance documents published this week from the FDA, EMA and ICH.  The usual collection of non-guidance documents also published including several slide decks from presentations made by EMA representatives. Enforcement saw publication of three drug warning letters, a handful of recalls, two consent decree agreements, and a few import alerts.  Nothing this week in the enforcement [...]

By |2018-06-12T04:15:35+00:00June 12th, 2018|Weekly Scans|

MONTHLY SCAN | May, 2018

Happy reading! Barbara FDA: ADMINISTRATIVE: The FR announced availability of a draft guidance, ‘Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food Drug, and Cosmetic Act Guidance for Industry’ ADMINISTRTIVE: The FR announced availability of a final guidance titled ‘Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act’ ADMINISTRATIVE: [...]

By |2018-06-07T12:25:38+00:00June 7th, 2018|Monthly Scans|

WEEKLY SCAN | May 27, 2018

This was a short week in the US with the Memorial Day holiday on Monday. The FDA published six guidance documents, WHO published one and EMA didn’t publish any in the areas we monitor. The non-guidance collection includes the usual from the FDA, EMA, MHRA and HPRA this week.  Among the more important announcements are the addition of two [...]

By |2018-06-04T20:34:24+00:00June 5th, 2018|Weekly Scans|

SPECIAL REPORT: FDA Data Integrity Enforcement Trends and Practical Mitigation Measures

The U.S. Food and Drug Administration (FDA) identified failures in data governance and data integrity starting approximately 20 years ago. Enforcement actions associated with these issues have increased since they initially appeared and are now at the forefront of highly visible FDA enforcement actions. This article provides a brief history of enforcement in the area, discusses enforcement trends and current [...]

By |2018-06-05T15:24:26+00:00June 4th, 2018|Special Reports|