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FDA Proposing More Transparency on Inspection Findings, Recalls, and Drug Filings

Jun 2nd, 2010

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An FDA task force released on May 19 a set of transparency principles for public comment which propose to change what GMP and CMC documents and information are available to the public and with what timing.  The proposals include making more information available more rapidly regarding GMP inspections, enforcement activities, and investigational, marketing and supplemental filings.

The “Transparency Task Force” launched Phase II of its three-phase initiative by releasing a report containing 21 draft proposals for expanding the disclosure of information by FDA while maintaining confidentiality for trade secrets and individually identifiable patient information. FDA is accepting public comment on the content of the proposals, as well as on which draft proposals should be given priority, on the FDA website’s task force page until July 20, 2010.

The transparency initiative, which began in June 2009, is divided into three phases:  Phase I, “FDA Basics,” was announced in January and is intended to provide the public with basic information about how FDA works, primarily through the web site at www.fda.gov/fdabasics;   Phase II is titled “Public Disclosure;” Phase III, “Transparency to Regulated Industry,” is set to begin in the Summer of 2010.

The agency notes that not all the proposals will necessarily be implemented, as some may require changes in law or regulation and some may require substantial amounts of resources.

The proposals are divided into eight categories, with varying numbers in each category:  Adverse Event Reports (1), Docket Management Process (1), Enforcement Priorities and Actions (2), Import Procedures (1), Inspections (2), Product Applications (10), Recalls (3), and Warning and Untitled Letters (1).

More on the FDA transparency initiative is provided for subscribers on page 2.  Links to related documents are also provided.
Note:  The June issue of IPQ will provide an in-depth report on the changing inspection and GMP enforcement landscape in the US, EU, and globally.

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