The Lachman Blog

10
Nov

Fran Zipp, Lachman Consultants’ CEO to Deliver Opening Address at 2020 ISPE Singapore Virtual Conference

(Westbury, NY— November 2020) Fran Zipp, Past International Board Chair, ISPE and CEO of Lachman Consultants is scheduled to deliver opening remarks at the 2020 ISPE Singapore Affiliate Conference & Exhibition. The three-day virtual event featuring programs, seminars, leading-edge technology, and presentations by top industry experts will take place Wednesday, December 9th through Friday, December […]

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10
Nov

Tidbits from the Monday AAM Afternoon Sessions – and Pay Close Attention to Little viii Carve Out Issue

We all know you can’t be in two places at once (although it would certainly be handy at times).  That applies to the Association for Accessible Medicines (AAM) meeting as well.  While there are lots of good sessions, as a one-man band, some tough choices had to be made. Let’s tackle one of the most […]

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09
Nov

Scott Deckenbach to Participate in Virtual Panel Discussion on the “New Normal” for Quality Practices During Pandemic

On November 11, 2020, Lachman’s Scott Deckebach MBA, Director, Compliance, Lachman Consultants will be participating in a panel discussion during the 2020 Bio/Pharma Virtual Congress, “‘New Normal’ for Quality Practices”. This discussion will review quality and regulatory challenges amid the pandemic, focusing on new technologies such as remote monitoring, risk-based quality management, Annex 1 changes […]

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05
Nov
Drawing of a happy smiling emoticon on a yellow paper and white background.

October 2020 Best Month in Last Eighteen for Generic Approvals

Unofficially, it appears that FY 2021 is being kicked off by the highest number of approval actions in the last eighteen months.  That’s right, it looks like the OGD will hit a total of at least ninety approval actions for October, which consist of at least seventy-seven full-approval actions and thirteen tentative-approval actions.  Why do […]

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04
Nov

Question: Which former acting deputy director of OGD just competed in Orange Book Jeopardy at AAMs Virtual GRx-Biosims Conference?

Answer: Who is Bob Pollock? Next week, November 9-11, the Association for Accessible Medicines (AAM) will be hosting a virtual version of the GRx+Biosims conference. As a part of it, an Orange Book Jeopardy was held between 3 Orange Book virtuosos: Kurt Karst of Hyman, Phelps & McNamara, David Rosen of Foley Lardner, and our […]

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04
Nov
Person wearing VR gear

Is FDA Finally Ready to Use Advanced Technology to Perform Inspections During the Pandemic?

According to the Pink Sheet, Brian Hasselbalch, in CDER’s Office of Pharmaceutical Quality, stated, at an IPAC-RS roundtable on November 2, 2020, that the FDA was developing guidance on virtual drug GMP inspections using interactive video or other types of interactive tools and techniques.  He noted that many companies have volunteered use of these types […]

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03
Nov

FY 2020 Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance

The FDA released its FY 2020 quarterly report of the Generics Drug Program late yesterday.  By the numbers, mean approval times reported by quarterly cohort have not changed significantly from quarter to quarter, and are driven by the age of the applications ready for and approved in that quarter. The Generics program has approved more […]

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