Monthly Archives: September 2018

//September

WEEKLY SCAN | September 16, 2018

A busy week for FDA on the guidance publication front.  Three address concepts in the DSCS Act regarding product identifiers.  EMA did not publish any this week and ICH published one. MHRA, EMA, FDA, and HPRA published items that were non-guidance.  FDA published three warning letters to drug firms, three to compounding pharmacies and one to a device firm.  [...]

By |2018-09-25T11:29:40+00:00September 24th, 2018|Weekly Scans|

WEEKLY SCAN | September 9, 2018

FDA was busy on the guidance/rule publication front this week.  Four publications addressed devices and two focused on Quality.  Among the later, the most relevant may be the draft guidance on post-approval changes to drug substance.  Because this draft guidance addresses  APIs supported by DMF filings, it would be interesting to consider whether any of these new requirements MAY [...]

By |2018-09-18T11:41:19+00:00September 18th, 2018|Weekly Scans|

WEEKLY SCAN | September 2, 2018

This was a short week in the US with the Labor Day Holiday. The US, EMA, Health Canada, CDSCO and ICH all published guidance documents this week. The EMA, MHRA, and FDA also published non-guidance documents this week. Enforcement actions published this week were limited to some Class II and III recalls and a couple of Import Alerts.  FDA [...]

By |2018-09-11T12:42:48+00:00September 11th, 2018|Weekly Scans|

MONTHLY SCAN | August, 2018

Happy reading! Barbara FDA: ADMINISTRATIVE: The FR announced the ‘Future Format of the National Drug Code;  Public Hearing’  Request for Comments. ADMINISTRATIVE: draft guidance ‘Expansion Cohorts:  Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics’ QUALITY: The FR announced the availability of a final guidance ‘Elemental Impurities in Drug Products’  finalizing a draft guidance [...]

By |2018-09-07T17:04:27+00:00September 7th, 2018|Monthly Scans|

WEEKLY SCAN | August 26, 2018

This week has just the bare essentials, I’m on vacation in Washington state doing a LOT of wonderful hiking with very little connectivity.  Next week will be back to normal…without the stunning scenery and hiking. Happy Reading, Barbara FDA: COMPOUNDING PHARMACIES: The FR announced that FDA is seeking comment on a proposal not to include bumetanide, nicardipine hydrochloride, [...]

By |2018-09-04T13:31:22+00:00September 4th, 2018|Weekly Scans|