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US FDA NOTICE DOCUMENTS |
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Health and Diet Survey:Dietary Guidelines Supplement- Report of Findings (2004 & 2005)
This report focuses on overall findings from the 2005 survey. Where appropriate, it also illustrates differences among the following subgroups: gender, education level, and age.(2) Prominent differences from the inaugural study conducted a year earlier are provided as well (italicized in text) for the purpose of highlighting potential areas of change that may deserve further investigation. Full document...
Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies for Purposes of the Food and Drug Administration Amendments Act of 2007
The Food and Drug Administration (FDA) is issuing this notice to notify holders of certain prescription new drug and biological license applications that they will be deemed to have in effect an approved risk evaluation and mitigation strategy (REMS) under the Food and Drug Administration Amendments Act of 2007 (FDAAA). Full document...
Inspection and Field Testing of Radiation-Emitting Electronic Products
This document represents the agency’s current thinking on the enforcement of the Federal Food Drug and Cosmetic Act Electronic Product Radiation Control provisions and related regulations. Full document...
New Law Ensures Access to Medical Treatments and Information
Legislation Reauthorizes Key User Fee Programs
Following the President’s signature of the Food and Drug Administration (FDA) Amendments Act, HHS Secretary Mike Leavitt praised the bill as an important step forward in ensuring the safety of drugs and medical devices.
Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 - Update
Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding blood, blood components or blood products.
FDA Statement on Gene Therapy Clinical Trial
On July 24, 2007 the U.S. Food and Drug Administration (FDA) was informed by Targeted Genetics Corporation of Seattle about the death of a patient who received an investigational gene therapy product in a clinical trial for the treatment of active inflammatory arthritis.
Questions and Answers Concerning the June 19, 2007 Final Rule: Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing; and Related Labeling
FDA completed rulemaking that put in place requirements to help prevent the transmission and spread of communicable disease by human cells, tissues, and cellular and tissue-based products (HCT/Ps). Full document...
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