In February 2014, then FDA Commissioner Margaret Hamburg issued a memorandum directing all Centers and the Office of Regulatory Affairs (ORA) to develop a plan for more collaboration and efficiency in operations. As a result of this mandate, the Centers and ORA have developed fiscal year plans to move toward a distinct commodity-based, vertically-integrated regulatory […]
FDA’s drug shortage list has a total of 60 drug products in the “currently in shortage” status (see list here). As you can see from the table below, injectable products are leading the list with 46 drug products currently in shortage. The second leading category are solid oral dosage forms and then just a […]
Back in January 2016, we posted a blog that described a revision in the bioequivalence (BE) Guidance for Paliperidone Palmitate extended-release suspension for intramuscular use (here). That draft Guidance revision was dated December 2015, just a few months ago. Now another revision takes its place. Some interesting changes are noted. We reported that the December […]
As a group of consultants to domestic and international pharmaceutical companies, we work with many clients responding to inspectional findings from an FDA inspection. At the close of the inspection, an FDA-483, Inspectional Observations form, may be issued to the firm’s management outlining conditions, which the FDA investigator(s) believe may constitute deviations from applicable law […]
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 This Guide supplements the above referenced draft Guidance and outlines how the FDA would like the information on quality metrics collected and reported.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 […]
