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 […]
With much activity still surrounding compounding pharmacies and outsourcing facilities, and with enforcement action still on the rise, today FDA issued two final Guidance documents that describe the types of bulk drug substances that can be used for compounding for section 503A (pharmacies) and 503B (outsourcing facilities) without FDA enforcement action. This also obviously assumes […]
We are pleased to announce that Ricki A. Chase will join Lachman Consultants as a Director in the Compliance Practice, effective June 20, 2016. Ricki Chase comes to Lachman Consultants after an impressive 16-year career, culminating as Director, Investigations Branch at the U.S. Food and Drug Administration where she was responsible for all operations of […]
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 […]
Today, the FDA announced the availability of a draft Guidance titled “Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for Abbreviated New Drug Applications” (here). The document discusses the way in which sponsors should document the adhesion of their proposed product with that the of reference listed drug (RLD). Clearly, for a generic transdermal […]
We have all read about the issue of pay-for-delay, where a generic company gets something in return for a patent settlement and agrees not to market a product for a period of time. The Federal Trade Commission (FTC) is aggressively pursuing such cases as anticompetitive,but that is a topic for another day. Now we may […]
