Regulatory Roundup: FDA Reorganizes the Office of the Commissioner, More...

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, FDA publishes draft guidances of two ICH Annexes; EMEA sets format for compliance advice; more...

The US Food and Drug Administration is reorganizing the Office of the Commissioner (OC), according to an Aug. 18 Federal Register announcement. Being realigned are four Deputy-level offices: the Office of the Chief Scientist; the Office of Administration (formerly titled the Office of Operations); the Office of Foods; and the Office of Policy, Planning and Budget (formerly titled the Office of Policy, Planning and Preparedness). Read the full details.

FDA also announced in the Aug. 18 Federal Register an extension of the public period for its transparency initiative. FDA’s Transparency Task Force is looking for industry’s feedback on ways it can be more open about agency activities and expectations. Comments can now be submitted through Nov. 6, 2009. Industry can also provide comments through the agency’s transparency blog.

FDA published two rules on Aug. 12 to “clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don’t have other satisfactory treatment options.” The new rules focus on expanded access to and charging patients for investigational drugs, ultimately making these experimental drugs more widely available to patients by clarifying procedures and standards and by clarifying the specific circumstances, acceptable costs, and procedures for the manufacturer. FDA also plans to launch a website to help patients and healthcare professionals learn about investigational drug options including how to gain access to an investigational drug. The idea is to allow patients who may need these drugs but do not wish to or cannot enroll in clinical trials to gain access to them.

FDA published as draft guidances the Step 3 version of two ICH Annexes (Annex 9 and Annex 10) to Q4B in the Aug 14 Federal Register. The Annexes address the Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability General Chapter and the Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter. The annexes reached Step 3 (regulatory discussion and consultation among the ICH parties) in June 2009. Annex 9 recommends that the analytical procedures described in the official pharmacopoeial texts for the US (Tablet Friability), Europe (Friability of Uncoated Tablets), and Japan (Tablet Friability Test), and USP can be used interchangeabley in the ICH regions. For interchangeability, the text adds that “the loss of mass for a single determination should be not more than 1.0%, unless otherwise specified in the dossier. When three determinations 116 are conducted, then the mean loss of mass for the three determinations should be not more than 1.%, unless otherwise specified in the dossier.” Annex 10 states that the pharmacopeial texts from the US (biotechnology-dereced articles: polyacrylamide gel electrophoresis), Japan (SDS–Polyacrylamide gel electrophoresis), and Euorpe (sodium dodecyl suplphate polyacrylamide gel electrophoresis) can be used interchanably in the ICH regions. Comments on both draft guidances are due Oct. 13, 2009.


The European Medicines Agency (EMEA) is now putting a schedule and format requirement on industry requests for compliance advice. Beginning Oct. 12, 2009 for companies who have not yet had a presubmission meeting and Oct. 19 who have had a presubmission meeting, the agency will only accept electronic submissions for scientific advice and protocol assistance requests, according to the EMEA website. Applications should be submitted only on a CD or DVD. Companies typically make these types of requests when there is not enough detail in existing European guidelines or monographs.

EMEA issued updated treatment recommendations to deal with the supply shortage of Cerezyme (imiglucerase for injection) in a press release. As reported in last week’s ePT, the Cerezyme shortage stems from a viral contamination at Genzyme’s manufacturing facility in Alston Landing, Massachusetts.