Monthly Archives: December 2018


WEEKLY SCAN | December 16, 2018

Both FDA and EMA published two guidance documents this week.  There is the usual collection of non-guidance documents from MHRA, FDA, EMA, and HRPA and Health Canada this week. Enforcement was a bit light on warning letters.  One to a drug manufacturer and a scathing one to a firm manufacturing human cell and tissue derived products.  This one identifies [...]

By |2018-12-26T04:55:46+00:00December 26th, 2018|Weekly Scans|

WEEKLY SCAN | December 9, 2018

A busy week on the guidance front from the FDA.  At long last the final Data Integrity Guidance Q&As published.  The draft guidance on GMPs for Outsourcing Facilities also was made available for comment.  A handful of biosimilar guidance published, some draft, some final. And finally, a couple of administrative documents were made available. A final guidance on site [...]

By |2018-12-18T11:47:38+00:00December 18th, 2018|Weekly Scans|

WEEKLY SCAN | December 2, 2018

A light week for guidance documents, the FDA published one device guidance, one proposed rule, and a final guidance for generic drug manufacturers.  The EMA didn’t publish anything in the areas we routinely cover.  The HPRA published new guidance for wholesale distributors. Among the non-guidance documents released this week, MHRA published a couple of pharmacovigilance metric summaries, EMA published [...]

By |2018-12-11T11:38:52+00:00December 10th, 2018|Weekly Scans|

MONTHLY SCAN | November, 2018

Happy reading! Barbara FDA: GENERAL: The FR announced that FDA is opening a public document regarding Prescription Drug-Use-Related Software DEVICES: The FR announced the publication of premarket approval applications and humanitarian device exemption applications that have been approved. DEVICES: The FR announced availability of a final guidance that is immediately effective, ‘Unique device Identification: Policy Regarding Compliance Dates [...]

By |2018-12-06T14:59:13+00:00December 6th, 2018|Monthly Scans|

WEEKLY SCAN | November 25, 2018

Happy Reading, Barbara FDA: DEVICES: The FR announced availability of a draft guidance ‘Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies’. DRUGS: The FR announced availability of draft and revised Product-Specific Guidance. DRUGS: The FDA released MAPP 4190.1 Rev 3, Drug Shortage Management EMA: SAFETY: Reflection paper on the qualification of non-genotoxic impurities  [...]

By |2018-12-04T12:52:53+00:00December 3rd, 2018|Weekly Scans|