The Lachman Blog

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11
Nov

Data Integrity Webinar – Manufacturing & Quality – A Lachman Learning Experience

Data integrity is an ever-increasing concern in life sciences evidenced by the recent activities of the FDA placing its watchful eye on the evolving medical device industry, for the purpose of ensuring safety, and enhancing quality among all manufacturers. Coming under recent scrutiny in the area is data integrity and its far-reaching impact on manufacturing […]

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10
Nov

AAM Meeting Day 3

The morning sessions opened with the usual USP presentation, which described its efforts domestically and globally and its goals for establishing quality metrics for products. After USP’s presentation, Christine Simmon led a manufacturers’ roundtable called Ensuring Biosimilars Sustainability.  The discussions focused on the impact of rebates and the uptake of biosimilars.  The group agreed that […]

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10
Nov

AAM’s GRx-Biosims Day 2 – Afternoon Sessions 

The afternoon sessions of the conference that I was able to attend included a discussion of Combination Products and Similarity, and two legal-based sessions, one on Approval Pathways for Complex Generics – 505(j) vs. 505(b)(2) and the other on Generic Drug Case Law. The combination product similarity session described the various permutations of the sameness […]

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09
Nov
Back view business woman raising hand for asking speaker for question and answer concept in meeting room for seminar

AAM GRx-Biosims Meeting – Day Two, Morning

For those of us on the West coast, it was an early wakeup this morning, but well worth it!  Here are some highlights from the GRx-Biosims conference morning sessions. Dr. Sally Choe, Director, Office of Generic Drugs (OGD), opened the morning with the OGD keynote address.  Dr. Choe outlined the OGD’s performance during the pandemic, indicating that […]

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09
Nov

AAM GRx-Biosims Day 1 – Afternoon, Part II

The other session that I was able to monitor was the Cares Act – Additional Reporting Requirements for Manufacturers. The purpose of the new reporting requirements is to proactively identify potential drug or API shortages so that the FDA can begin to act and perhaps institute a flexible regulation approach to mitigate the shortage.  The […]

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08
Nov

FDA Announces the Issuance of New PSGs

Today, FDA issued a Federal Register notice (here) announcing the release of 24 new product specific guidances (PSGs) and 20 revised guidances. These guidances provide the FDA’s current thinking on the methods to establish bioequivalence for specific products. The new and revised guidances can be found on the FDA webpage here. Please note that, as […]

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05
Nov

A Look at the Reporting Requirements Described in the GDUFA III Commitment Letter

The FDA is changing its reporting requirements for GDUFA III.  It appears from the changes that some information may be more difficult to gather and will be removed from the monthly Generic Drugs Program Activities Report we have all come to love and will be moved to either quarterly or annual reports. The monthly report […]

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