June 2016

29
Jun

Proposed Rule Issued Based on Tentative Final Monograph for Waterless Hand Rubs for Consumers

The Proposed Rule based on the Tentative Final Monograph (TFM) (here) is a 101-page monster that addresses consumer-type hand rubs that are designed to be used without water – generally, what one might think of as “hand sanitizers” (or “consumer antiseptic rubs” as the FDA terms them).  The Proposed Rule DOES NOT cover “OTC consumer […]

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29
Jun

Technical Reference Document Letter

On June 27, 2016, FDA announced in the Federal Register the issuance of a Technical Reference Document titled “Quality Metrics Technical Conformance Guide”. This Guide is meant to supplement the FDA Guidance titled “Request for Quality Metrics” in that it provides technical recommendations for the submission of quality metrics data called for in the Guidance. […]

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29
Jun
What’s the Delay, FDA Image

What’s the Delay, FDA?

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 […]

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28
Jun

Important Note: There Are Two Different Everolimus Bioequivalence Guidance Recommendations – Be Careful Which You Rely Upon

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) […]

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24
Jun

Technical Reference Document Issued for Quality Metrics

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 This Guide supplements the above referenced draft Guidance and outlines how the FDA would like the information on quality metrics collected and reported.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 […]

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19
Jun
Here Is Something to Chew On Image

Here Is Something to Chew On

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 […]

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16
Jun

New BE Requirements for Propofol Injection

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 […]

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