Compliance

13
Jul

FDA SUPPORTS SHARING FEEDBACK ON INVESTIGATOR CONDUCT DURING INSPECTIONS

If you work in regulated industry, you will eventually be inspected by the Food and Drug Administration (FDA).  With each inspection comes an opportunity to forge good working relationships with the individuals on the forefront of your compliance status.  With so much riding on any given inspection, what do you do if problems arise with […]

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08
Jul

Additional Guidance for Compounders of Commercially Available Copies of Products

Yesterday, FDA issued two draft Guidance documents that address the compounding of essentially commercially available drug products.  The two documents, one for compounding pharmacies under Section 503A of the Act (here) and the other that addresses outsourcing facilities under Section 503B of the Act (here) describe FDA’s view of how the issue of compounding essentially […]

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06
Jul
FDA’s Program Alignment: More Questions Than Answers Image

FDA’s Program Alignment: More Questions Than Answers

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 […]

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05
Jul
Its Elemental, My Dear Watson Image

Its Elemental, My Dear Watson

The FDA recently issued a draft Guidance document; entitled “Control of Elemental Impurities in Drug Products”.  This document provides guidance in light of the issuance of ICH Q3D Elemental Impurities and USP<232> Elemental Impurities – Limits and USP<233> Elemental Impurities – Procedures. USP <232>.  Upon implementation (scheduled Jan 1, 2018), USP<232> and USP<233> will replace […]

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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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