Monthly Archives: April 2019

//April

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Happy Reading, Barbara FDA: BIOLOGICS: The FR announced availability of a draft guidance for industry ‘Nonproprietary Naming of Biological Products Update’.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|