The Lachman Blog

27
Oct

FDA Finalizes Guidance on Referencing Approved Drug Products in ANDA Submissions

Initially issued in draft in 2017, the document “Referencing Approved Drug Products in ANDA Submissions – Guidance for Industry” was issued in final today.  It addresses the difference between the reference listed drug (RLD) (that must be cited as the basis of the ANDA submission) and the reference standard (RS), and provides details of how the […]

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22
Oct
Businessman examines a tablet with a magnifying glass. Concept of internet security

Understanding Risk as It Applies to Data Integrity

The PDA published Technical Report 84, Introducing Data Integrity Requirements into Manufacturing and Packaging Operations (here), which reaffirms that Data Integrity is not only a concern for the laboratory but for any aspect of the pharmaceutical industry where data/records are generated and handled.  There are excellent tools within the document as it applies to the […]

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19
Oct

FDA/DOJ Gets Tough on Illegal Dietary Ingredient DMAA

Two executives of a dietary ingredient company were sentenced to sixty months and twenty-four months in prison, respectively, for their part in the distribution of two products, Jack3d and OxyElite Pro, touted as workout weight-loss supplements, both containing DMAA, according to a Department of Justice release (here).  The FDA had warned consumers about the dangers […]

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16
Oct

End of FY 2020 Approvals, Receipts, CRLs, and Updates to August Metrics

FDA reported 70 full approval actions and 15 tentative approval actions in September for a total of 85 approval actions for the month.  The 85 approval actions fell into the second most approval actions in FY 2020 behind only April’s total of 87.  The full approval action in September was also the second highest this […]

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15
Oct

Extension Sought on Comments Regarding Patent Listing

On June 1, 2020, in Docket FDA-2020-N-1127 and published in the Federal Register, the Agency asked for public comment regarding updating and clarifying the types of patents that could be listed in the Orange Book (here).  The document sought comments on two specific issues of continued interest: should patents be submitted to the FDA and […]

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11
Oct

Holy Cow, Revised MaPP on ANDA Suitability Petitions – Now What Does This Mean?

Well, in my book, any movement on 505(j)(2)(C) ANDA suitability petitions is welcome news.  The pool of pending ANDA suitability petitions is full at FDA and is, by now, becoming very stagnant.  There has been little action on 505(j)(2)(C) petitions in the last 10 years.  Just last year, out of the blue, we got two […]

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08
Oct

Lachman Consultants Attendance at ISPE 2020 Virtual Meeting & Expo to Feature Innovative Consultant Services

(Westbury, NY – October 2020) Lachman Consultants Services, Inc. (Lachman Consultants), a provider of compliance, regulatory, and technical consulting services to the global pharmaceutical and related industries, has announced that it will be an active participant at the 2020 ISPE Annual Meeting and Expo, Monday, November 2nd  through Friday, November 6th, 2020. Entitled “Driving the […]

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07
Oct

Are ADHD/Stimulant Drugs Dropping Off the FDA’s ADF Radar?

This morning, in reading an article from the Pink Sheet written by Sarah Karlin-Smith, I flashed on my blog post from September 24, 2020 (here) discussing the new warning on benzodiazepine products.  In this post, I had expressed concern that the abuse-deterrent formulation (ADF) craze of opioid formulations might be creeping in on other products […]

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05
Oct
Person wearing VR gear

Lachman Consultants Launches 3-D Virtual Inspections for Life Science Clients

New Technology Resolves On-Site Inspection Challenges Amid Pandemic (Westbury, NY – October 2020) Lachman Consultants Services, Inc. (Lachman Consultants) is introducing Virtual Touring, a state-of-the-art experience that allows manufacturing facilities to safely conduct virtual inspections, tours and visits, even in the midst of the COVID-19 pandemic. This technology is vital to the Life Sciences industry, […]

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