Monthly Archives: August 2018


WEEKLY SCAN | August 19, 2018

This week was slower than last week both in the publication of guidance and enforcement actions.  The FDA published two guidance documents and a request for applications for the FDA site visit program in FY2019.  EMA didn’t publish guidance in the areas we routinely follow.  WHO and Russia also published guidance. The guidance from Russia addresses data integrity, and [...]

By |2018-08-28T13:16:27+00:00August 27th, 2018|Weekly Scans|

WEEKLY SCAN | August 12, 2018

We see new guidance this week from FDA, EMA, CDSCO, ICH and WHO.  MHRA, FDA and EMA and HPRA also have non-guidance publications this week. After a few weeks where a limited number of enforcement actions published, this has been a busy week.  One of the posted warning letters was issued to a GLP site and six were issued [...]

By |2018-08-21T17:06:24+00:00August 20th, 2018|Weekly Scans|

WEEKLY SCAN | August 5, 2018

It’s August already and school starts soon!  Where did the summer go? FDA published a variety of guidance documents in the areas of Quality, Generics, combination products and general administrative requirements.  Six guidances in total. EMA and TGA each published one. Non-guidance publications include the usual collection from MHRA, FDA, EMA and WHO.  The EMA annual report for 2017 [...]

By |2018-08-14T13:17:16+00:00August 14th, 2018|Weekly Scans|

MONTHLY SCAN | July, 2018

We include a brief supplement this month looking at drug GMP warning letters issued in the first half of 2018. Happy reading! Barbara FDA: GENERICS: The FR announced availability of a final guidance ‘Abbreviated New Drug Application Submissions—Amendments to Abbreviated New Drug Applications Under the Generic Drug User Fee Act. ‘  Here’s an assessment from Lachman Consultants. GENERICS: [...]

By |2018-08-09T14:04:38+00:00August 9th, 2018|Monthly Scans|

WEEKLY SCAN | July 29, 2018

Another collection of FDA User Fee Rates for FY2019 was released including those for drugs, outsourcing facilities, and biosimilars. EMA published several items including a broad draft guideline that covers gene therapy products including the CAR-T family of products.  WHO published three guidances for consultation;, HPRA, Health Canada and PIC/S each published one item. Enforcement picked up this week [...]

By |2018-08-07T13:36:17+00:00August 7th, 2018|Weekly Scans|