Monthly Archives: October 2019

//October

WEEKLY SCAN | October 20, 2019

Two of the three guidance from FDA this week address homeopathic products.  Perhaps the FDA is finally beginning their ‘modernization’ of the regulation of these products.  None too soon!  Other guidance is provided by Hong Kong, Malaysia and TGA.  We also provide the usual collection of non-guidance publications. Enforcement this week includes only two drug warning letters, one of [...]

By |2019-10-29T11:41:46+00:00October 29th, 2019|Weekly Scans|

WEEKLY SCAN | October 13, 2019

This was a light week in terms of guidance publications.  The non-guidance group however continues to be busy.  The first bullet point under the EMA in the non-guidance area regarding assessments for nitrosamines for MAHs is a must read for any firm that manufactures chemically synthesized APIs.  Section 12 of this Q&A is new and addresses the potential cause [...]

By |2019-10-22T11:57:42+00:00October 22nd, 2019|Weekly Scans|

WEEKLY SCAN | October 6, 2019

Three guidance documents from FDA, one from EMA and one each from Malaysia and ICH.  The non-guidance area has some valuable items including an Excel spreadsheet from MHRA identifying GMP deficiencies in the second bullet point under MHRA.  MHRA continues to publish revisions / guidance should a no-deal Brexit become a reality at the end of October. Enforcement has [...]

By |2019-10-15T11:46:13+00:00October 15th, 2019|Weekly Scans|

MONTHLY SCAN | September, 2019

Happy Reading, Barbara FDA: DEVICES: The FR announced availability of a final guidance, ‘Acceptance Review for De Novo Classification Requests’. DEVICES: The FR  announced availability of a final guidance, ‘FDA and Industry Actions on De Novo Classification Requests:  Effect on FDA Review Clock and Goals.’ DEVICES: The FR announced availability of a final guidance ‘User Fees and Refunds [...]

By |2019-10-12T14:25:00+00:00October 10th, 2019|Monthly Scans|

WEEKLY SCAN | September 29, 2019

Lots of good stuff this week, mostly in the non-guidance area.  FDA published four guidance items and the EMA/EC published two. Three drug warning letters including the one issued to Lupin Limited which seems to show they haven’t corrected their shortcomings since the November 2017 warning letter.  Recalls included one Class I, several Class II and one Class III.  [...]

By |2019-10-08T10:33:14+00:00October 8th, 2019|Weekly Scans|

WEEKLY SCAN | September 22, 2019

LOTS of guidance this week from FDA, particularly from CDRH, this must be the end of the fiscal year push to make goals and timelines. We also include two from EDQM and two from PIC/S. Lots of non-guidance publications include a collection from the usual sources:  MHRA, EMA, FDA and HPRA. No drug GMP warning letters this week, a [...]

By |2019-10-01T10:51:56+00:00October 1st, 2019|Weekly Scans|