I railed about drug importation as a way to lower drug costs in a previous post (here) for numerous reasons. For instance, how can you protect against counterfeit drugs, how do you know how the products are stored and where they have been in the supply chain, and how are you assured of drug product […]
Contract Pharma published an article in April addressing the need for a modernized version of “our generic drug review process.” FDA anticipates a data-based assessment will “improve consistency, transparency, communication, and objectivity of regulatory actions as well as knowledge management within the Agency.” Knowledge-aided Assessment & Structured Application (KASA) is in support of the Generic […]
In a Federal Register Notice to be published tomorrow (here), the FDA announced GDUFA User Fees that will be in effect for Fiscal Year 2020, which begins on October 1, 2019 and continues through September 30, 2020. There is some good news and some bad news. Here are the application, DMF, and facility fees for FY […]
According to the FDA, OGD approved 11 ANDAs for Pregabalin (a generic for Lyrica), on Friday, July 19, 2019. However, when looking at the Innovator product’s patent and exclusivity awards, the 180-day pediatric exclusivity expired on June 30, 2019. This got my mind working to try to figure out why the 17-day (June 30 fell […]
In a 21 page response (here) dated July 18, 2019 to Citizen Petition Docket No. 2019-P-0837 (here ), filed on February 20, 2019, the FDA determined that a carve out of an exclusivity-based and patent-based (potential little viii) statements regarding a supplemental application approval granting the inclusion of information on treatment of emergent sexual dysfunction […]
With just eleven of the twenty-two working days left in July for the OGD to report approval actions, the number of full approval actions stands at twenty-nine and tentative approval actions sit at eight, for a total of thirty-seven so far this month. These numbers are derived from the FDA’s All Approvals page here. Compared […]
FDA has announced the availability of another draft guidance for industry entitled, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process. The draft guidance is part of FDA’s continued support of the Drug Competition Action Plan and to encourage the generic industry to take advantage of the USP’s Pending Monograph Process that was […]
OGD released its official approval and receipt numbers on Wednesday afternoon and, as was predicted (almost) in our previous blog (here), it was somewhat disappointing. We missed the approval actions by one. OGD actually issued 45 approval actions (we found only 44), and they issued 17 (as predicted) tentative approval actions for a total of […]
Today, the FDA issued a draft guidance titled Using the Inactive Ingredient Database (here). The guidance describes how to use the inactive ingredient database (IID) and its limitations. FDA has been using the IID since 1987 and has committed to updates throughout the year that provide more current and useful information. Excipients are constantly being […]
On July 9, 2019, FDA finalized the Guidance for Industry titled, Risk Evaluation and Mitigation Strategies: Modifications and Revisions. The current Guidance updates the previous Guidance with the same name that was issued on April 7, 2015. The update is more of a finalization; the portion of the draft that sets forth the submission procedures for […]
