The Lachman Blog

15
Apr

Remote Inspection Guidance Now A Reality But Will It Solve the Backlog of Inspections?

Yesterday, the FDA issued a long-awaited guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency (here).  The guidance notes that the Agency will determine whether remote inspections will occur and which tools are appropriate as alternatives to on-site inspections but indicates that it will not accept […]

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12
Apr

OGD Updates February Statistics

OGD updated and provided the remainder of its monthly metrics for February 2021 in its Generic Drugs Program Activities Report – Monthly Performance (here).  Here are some interesting observations! OGD issued 7 refuse-to-receive (RTR) actions which is the most since January 2020 when they also issued 7 RTR actions.  All were for standard ANDA applications. […]

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12
Apr

Examples of Many of the Catch 22s of Controlled Correspondence with the FDA

Okay, so you want to bring a product back from the dead.  That is, you want to file an ANDA for an older discontinued product without competition and with no designated reference listed drug (RLD) or reference standard (RS) published in the Orange Book (OB).  Oh yeah, and you also want to start a development […]

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08
Apr

False Negative COVID-19 Tests Further Complicated by Variants

The FDA notes that many of the emergency use authorization (EUA) tests currently being utilized are subject to false-negative results.  The FDA emphasizes (here) that variants seen in the virus may have a significant impact on COVID-19 tests and this will likely occur with greater frequency, especially as some of the variants become predominant in […]

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06
Apr

Guidance for ANDAs –Development During Covid-19 – Q&A Document

Yesterday, the FDA issued a guidance document titled Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers (here).  The guidance covers three broad areas: Generic drug product development ANDA submission and assessment and Marketing and exclusivity. The guidance offers many hints on how the Agency may deal with issues that […]

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01
Apr

80 Products Approved with CGT Designation Thus Far

The FDA has released its most current list of Competitive Generic Therapy (CGT) ANDA approvals (here).  CGT-designated products (products for which there is little, if any, generic approvals for NDA products) may be eligible to receive 180-days of market exclusivity from a subsequent ANDA approval for the same strength and product. After any ANDA approval […]

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