As far as the available numbers for ANDA approvals and tentative approvals goes, for June, it appears we will have in the neighborhood of 67 full approvals and 6 tentative approvals for the month, more or less in line with what we have seen in the past few months. These numbers were derived from the FDA All Approvals list (here) and the FDA Approved Drug Products list of daily approvals (here).
Today, as a 4th of July present, and in anticipation of celebratory fireworks, the FDA has issued a final guidance entitled ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA (here). The final guidance explains that the complex tiered amendment classification system of GDUFA I was abandoned to provide a less cumbersome and more straightforward classification of amendment types,
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We at Lachman are very excited to announce our recently opened first European office. The new office is located in the heart of beautiful Switzerland near Lake Lucerne (Luzern). This centrally-located European office gives us easier access to our clients in Europe, Asia, and the surrounding regions.
FDA Commissioner Scott Gottlieb issued a statement (here) on the Agency’s continuing position related to compounded drugs for patients that cannot use an FDA approved product. However, the bent taken in his statement leans more towards the issues of safety and efficacy, while he points to the Department of Justice’s (DOJ) recent healthcare fraud enforcement actions related to the use of multi-component compounded products thought to artificially increase billing rates for these compounded products.
On June 25, 2018, the Association of Accessible Medicines (AAM) submitted comments to Docket FDA-2017-N-6644: Generic Drug User Fee Amendments Reauthorization of 2017; Regulatory Science Initiatives; Public Workshop and provided some very interesting and relevant comments and suggestions. The full text of the AAM comments can be found here, but here is a peek into the basket of suggestions.