Monthly Archives: August 2019

//August

WEEKLY SCAN | August 18, 2019

A sparse week for guidance, none at all.  Maybe everyone is on vacation!  Lots of non-guidance publications though. Enforcement includes three drug warning letters, one to a compounding pharmacy and one to a device manufacturer.  We also have a large collection of forms-483 issued to compounding pharmacies in April and May of this year!  We provide a single form [...]

By |2019-08-27T13:08:17+00:00August 27th, 2019|Weekly Scans|

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|