Thursday, June 19, 2008

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update: 1

From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 18 Jun 2008 06:28:56 -0500 (CDT)
Subject: CDRH New Update

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CDRHNEW Logo Date: June 18, 2008

The following new items were added to the CDRH web pages on June 17, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

* Office of Science and Engineering Laboratories (OSEL) Fiscal Year 2007 Annual Report Text PDF

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Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 18 Jun 2008 07:29:49 -0500 (CDT)
Subject: CDER's Small Business Assistance Bulletin

Small Business Assistance (SBA) in the Center for Drug Evaluation and Research (CDER) provides assistance to businesses with less than 500 employees in the development of new pharmaceutical products. Through an extensive outreach program SBA provides guidance and information to small pharmaceutical businesses through its ListServ, Q&A's, workshops, and website. The ListServ provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical businesses which includes Federal Register notices, guidances, workshop announcements, etc. The following information is being sent to you via e-mail.

1. The Food and Drug Administration announced in a Federal Register notice of June 12, 2008, the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--Postmarketing Individual Case Safety Reports.'' This draft guidance consolidates and revises information in two existing draft guidances pertaining to electronic submission of postmarketing individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments). The submission of ICSRs and ICSR attachments in an electronic format significantly improves the agency's efficiency in processing, archiving, and reviewing the reports. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-13269.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2001-D-0067-gdl.pdf

2. The Food and Drug Administration announced in a Federal Register notice of June 12, 2008, the availability of a draft guidance for industry entitled ``Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and make those findings publicly available. This draft guidance informs industry of how FDA intends to comply with the FDAAA requirement. Specifically, the draft guidance describes procedures and responsibilities for updating information on susceptibility test interpretive criteria, susceptibility test methods, and quality control parameters in the labeling for systemic antibacterial drug products for human use. This draft guidance also describes procedures for making corresponding changes to susceptibility test interpretive criteria for antimicrobial susceptibility testing (AST) devices. http://www.fda.gov/OHRMS/DOCKETS/98fr/08-1350.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0339-GDL.pdf

3. The Advisory Committee for Pharmaceutical Science and Clinical Pharmacology meeting will be held July 22 and 23, 2008, from 8:30 a.m. to 5 p.m. at the Food and Drug Administration, Center for Drug Evaluation and Research, Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD. The agenda: includes the following: (1) Receive presentations from the Office of Pharmaceutical Science (OPS) and discuss current thinking on issues pertaining to the use of nanotechnology in drug manufacturing, drug delivery, or drug products, and (2) receive an update from OPS, discuss, and make comments on current strategies and directions for the testing of lead in pharmaceutical products. On July 23, 2008, the committee will do the following: (1) Receive and discuss presentations from the Office of Generic Drugs (OGD) on the bioequivalence methods for locally acting drugs that treat gastrointestinal (GI) conditions, (2) receive and discuss presentations from OGD on the use of inhaled corticosteroid dose-response as a means to establish bioequivalence of inhalation drug products, and (3) receive and discuss presentations from OPS on the drug classification of orally disintegrating tablets (ODT) as a separate dosage form, and the need for subsequent guidance on expectations and recommendations that would be required for applications proposing the dosage form. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-12646.pdf

4. The Food and Drug Administration announced in a Federal Register notice of June 2, 2008, the availability of a guidance for industry entitled ``Indexing Structured Product Labeling.'' This guidance explains that the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) will index structured product labeling (SPL) in the product labeling for human drug and biologic products. This guidance also makes recommendations to industry on how to submit input regarding the indexing information in the SPL. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-12158.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2007-D-0364-gdl.pdf

5. The Food and Drug Administration proposed in a Federal Register notice of June 2, 2008, to amend its regulations concerning the format and content of the ``Pregnancy'', ``Labor and delivery'', and ``Nursing mothers'' subsections of the ``Use in Specific Populations'' section of the labeling for human prescription drug and biological products. The agency is proposing to require that labeling include a summary of the risks of using a drug during pregnancy and lactation and a discussion of the data supporting that summary. The labeling would also include relevant clinical information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and/or lactation. The proposal would eliminate the current pregnancy categories A, B, C, D, and X. The ``Labor and delivery'' subsection would be eliminated because information on labor and delivery is included in the proposed ``Pregnancy'' subsection. The proposed rule is intended to create a consistent format for providing information about the effects of a drug on pregnancy and lactation that will be useful for decisionmaking by women of childbearing age and their health care providers. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-11806.pdf

6. The Rulemaking History for Nonprescription Products Drug Category List has been updated. This Over-the-Counter (OTC) drug category web site contains Federal Register notices organized by therapeutic category subtopics. Each web page also links to therapeutic category pages organized chronologically. http://www.fda.gov/cder/otcmonographs/rulemaking_index.htm

7. An Interactive Forum co-sponsored by FDA and Generic Drugs will be held on June 30 – July 1, 2008, in Bethesda, Maryland. http://www.pharmaconference.com/pharmaceutical_conferences/p_conf_brochures/June06_2008.pdf

8. The Food and Drug Administration sent warning Letters to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01852.html

Ron Wilson Director of Small Business Assistance wilsonr@cder.fda.gov

Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 18 Jun 2008 09:06:56 -0500 (CDT)
Subject: FDA Warning Letters Update

You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 18 Jun 2008 10:04:57 -0500 (CDT)
Subject: FDA Approves Diaphragm-Pacing Device

FDA Approves Diaphragm-Pacing Device
Wed, 18 Jun 2008 09:17:00 -0500

The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator.

Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 18 Jun 2008 12:05:01 -0500 (CDT)
Subject: United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release)

United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release)
Wed, 18 Jun 2008 11:28:00 -0500

U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People’s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety.

Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 18 Jun 2008 12:58:40 -0500 (CDT)
Subject: CDER New 6/16 & 17/2008

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June 17, 2008

  • FDA warns individuals and firms to stop selling fake cancer "cures" FDA News

June 16, 2008

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