FDAzilla GMP Regulatory Intelligence Newsletter

FDAzilla GMP Regulatory Intelligence Newsletter
FDAzilla GMP Regulatory Intelligence Newsletter 2018-04-02T01:58:47+00:00

Latest Issue

WEEKLY SCAN | April 8, 2018

A bit of a busier week than last week for guidance.  The FDA published six documents, nothing from EMA in the areas we follow.  WHO, CDSCO, Health Canada, TGA and HPRA also published guidance. Non-guidance publications from the usual sources, MHRA, EMA, FDA and we include one each from TGA and PMDA. Enforcement is still a bit light with one warning letter to a drug firm and one compounding pharmacy.  We include the usual collection of import alerts and [...]

By | April 16th, 2018|Categories: Weekly Scans|0 Comments

Special Reports

  • Integrity Guidance

April 10th, 2018|0 Comments

MHRA published a revision to their 2015 Data Integrity Guidance, finalizing the draft revision published for consultation in 2016.  The [...]

  • Data Governance and Data Integrity

March 15th, 2018|0 Comments

This Special Report represents the third year that we have published an evaluation of warning letters associated with data governance [...]

  • Inspection Observations

February 6th, 2018|0 Comments

A comprehensive GMP Intelligence program includes monitoring of health authority enforcement actions, including FDA forms-483, Establishment Inspection Reports, warning letters, [...]

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