/Barbara W. Unger

About Barbara W. Unger

Barb is the Editor in Chief of the GMP Regulatory Intelligence Newsletter. Go to our About page to read more.

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|

WEEKLY SCAN | September 15, 2019

A busy week for the FDA in their publication of guidance.  Devices and generics were among the most active.  MHRA, ICH and WHO also published one guidance each.  The non-guidance collection includes a blog entry from the MHRA,  their update on 2017 and 2018 GLP deficiencies and another FDA update on the ‘sartan’ recalls.  See also the actions that [...]

By |2019-09-24T13:15:36+00:00September 24th, 2019|Weekly Scans|

WEEKLY SCAN | September 8, 2019

Thanks for your patience with my vacation, but we’re all back to work again! I’ve picked up many of the published guidance that appeared in my absence, CDRH was busy,  but I may have missed one or two. Four of the CDRH guidance address the 510(k) program, three address de novo classification and the remaining two address the humanitarian [...]

By |2019-09-17T14:28:51+00:00September 17th, 2019|Weekly Scans|

MONTHLY SCAN | August, 2019

Happy Reading, Barbara FDA: ADMINISTRATIVE: The FR announced a public docket to collect comments on evaluating the clinical pharmacology of oligonucleotide Biologics: The FR announced the availability of the Agency’s annual report “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” DRUGS: The FR announced the availability of a final guidance for [...]

By |2019-09-05T11:48:56+00:00September 5th, 2019|Monthly Scans|

WEEKLY SCAN | August 25, 2019

NOTE:  There will be no newsletter published on Tuesday September 10 due to Barb’s vacation the previous week in areas without connectivity.  Great scenery and hiking, but no/limited internet. Once again we have a sparse week on the guidance front, with two items from FDA.  The non-guidance items however continue though there are fewer of them also.  End of [...]

By |2019-09-03T11:44:42+00:00September 3rd, 2019|Weekly Scans|

WEEKLY SCAN | August 18, 2019

A sparse week for guidance, none at all.  Maybe everyone is on vacation!  Lots of non-guidance publications though. Enforcement includes three drug warning letters, one to a compounding pharmacy and one to a device manufacturer.  We also have a large collection of forms-483 issued to compounding pharmacies in April and May of this year!  We provide a single form [...]

By |2019-08-27T13:08:17+00:00August 27th, 2019|Weekly Scans|

WEEKLY SCAN | August 11, 2019

A light week for new guidance. FDA published two and that was it!  We have the usual complement of non-guidance publications from the MHRA, EMA, FDA and one from China. In the enforcement area we cover three drug warning letters, one issued to a compounding pharmacy, one device warning letter and one in the food area that is a [...]

By |2019-08-20T19:12:50+00:00August 20th, 2019|Weekly Scans|