In the most recent update of the bioequivalence (BE) recommendations, there is a new Guidance for the conduct of BE studies for Everolimus dated June 2016. This specific Guidance covers the use of the drug in treating organ rejection (here). A previous Guidance document (initially issued in March 2011 and then revised in June 2012) […]
FDA has denied an interesting petition that requested a change in dosage form from a solid oral tablet of methimazole to a rapidly disintegrating tablet for cats. The Agency said in its denial letter: “Your proposed change from the RLNAD with the justification you cited from Hatch-Waxman Amendments, 1984, does not support the change you […]
The FDA today released a technical reference document entitled, “Quality Metrics Technical Conformance Guide for the Implementation of the Draft FDA Guidance for Industry on Requests for Quality Metrics.” This Guide supplements the above referenced draft Guidance and outlines how the FDA would like the information on quality metrics collected and reported. Remember that, as stated […]
OGD published an updated version of its Paragraph IV database (here)This database lists those products that are both first-to-file and have made a paragraph IV certification claiming that at least one patent on the reference listed drug (RLD) upon which its ANDA is based will not be infringed, or that the patent is invalid or […]
Ever had a tablet that was too big and you wished you could chew it? Well, some immediate-release tablets are designed to be chewable and carry such designation. The Guidance, titled “Quality Attribute Considerations for Chewable Tablets” (here), addresses the desired features of chewable tablets and describes the attributes that FDA evaluates when developing such […]
Today, the FDA issued 19 new and 19 revised bioequivalence (BE) recommendations for the conduct studies of products subject to abbreviated new drug applications (ANDAs). One of the new recommendation relative to propofol injection caught my eye. The issue of interest concerns the newly stated requirement for quantitative (Q1) and qualitative (Q2) sameness of the […]
The Creates and Restoring Equal Access to Equivalent Samples Act of 2016 (CREATES) (summary of the Act can be found here and the full Act here) is designed to stop the abuse of the restricted distribution systems and Risk Evaluation and Mitigation Strategies (REMS) programs. How do these two things impede generic access? Brand companies […]
Just two days after our Tentative Approvals and Receipts post (here), the Office of Generic Drugs (OGD) partially updated its Activities Report of the Generic Drug Program 2016 to include May approval statistics and new ANDA receipts. OGD approved 54 ANDAs and Tentatively Approved 20 ANDAs. (The FDA Monthly approval site still has listed only […]
Information on the FDA’s Monthly Approval Report (here) is usually not complete. Typically, there may be up to a 5-10% discrepancy (lower than actual) in the numbers of Approvals and Tentative Approvals reported. The discrepancy improves over time but seldom do the numbers actually match the reported number of approval actions on the Activities Report […]
Led by Senators Orin Hatch and Edward Markey with sign on by 20 other senators, a letter to Sylvia Burwell, the Secretary of Health and Human Services (HHS), encouraged an increase of the number of patients a single physician can treat in a Medication Assisted Therapy (MAT) program from the current 100 patient limit to […]
