Entries by Team Nexreg

Dec. 8 – FDA Advising of Risk of Birth Defects with Paxil

The Food and Drug Administration today is alerting health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Paxil is approved for the treatment of depression and […]

Dec. 7 – CPSC Signs MOU with Mexico to Improve Safety of Consumer Products

The U.S. Consumer Product Safety Commission (CPSC) today announced an agreement with the Mexican government aimed at further improving consumer safety and making both the United States and Mexican marketplaces among the safest in the world. This agreement is also part of the “Security and Prosperity Partnership” between the U.S., Mexico, and Canada. CPSC Chairman […]

Dec. 7 – FDA Seeks Input on Communication of Drug Safety Information

As part of the Food and Drug Administration’s continued commitment to improve communication about risks posed by prescription medications, its Center for Drug Evaluation and Research (CDER) is holding a public meeting today to evaluate current practices and to explore new tools and strategic partnerships to enhance future efforts. “In the past year we have […]

Dec. 5 – OSHA and SCHC Renew Alliance to Improve Hazcom and MSDS

Acting Assistant Secretary of Labor for Occupational Safety and Health Jonathan L. Snare today signed a two-year renewal of the Society for Chemical Hazard Communication (SCHC) Alliance that will continue to focus on providing information and education on hazard communication and chemical safety. Through the OSHA and SCHC Alliance renewal, the organizations will continue to […]

Nov. 29 – Final Significant New Use Rule Issued for 2-ethoxyethanol, 2-ethoxyethanol acetate, 2-methoxyethanol, and 2-methoxyethanol acetate

EPA is issuing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) which requires persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of 2-ethoxyethanol (CAS No. 110-80-5) (2-EE), 2-ethoxyethanol acetate (CAS No. 111-15-9) (2-EEA), 2- methoxyethanol (CAS No. 109-86-4) (2-ME), or […]

Nov. 28 – Validation Documentation Requirements and Responsibilities for Drug Fabricators, Packagers / Labellers, Testers, Distributors and Importers

A new version of the document entitled “Validation Documentation Requirements and Responsibilities for Drug Fabricators, Packagers / Labellers, Testers, Distributors and Importers” is now available. This document has been reviewed as part of the Inspectorate’s quality management process and has been amended to further clarify issues brought to the attention of the Inspectorate. Source

Nov. 24 – Final Report on Progress: Consultations on the CEPA New Substances Notification Regulations and New Substances Program (Chemicals and Polymers Portion)

This is the second, and final, formal report on the progress being made in implementing the recommendations resulting from the multistakeholder consultations that took place (1999-2001) on amending the New Substances Notification Regulations (NSNR) and the New Substances (NS) Program. Although this is the final formal progress report on the implementation of these recommendations, Environment […]

Nov. 17 – Compromise Moves REACH Closer To Reality

“The European Commission welcomes the fact that the European Parliament has completed its first reading on REACH. By supporting the Sacconi/Nassauer compromise on registration the EP strikes a very good balance between the health, environment and competitiveness goals of REACH. The Commission will carefully assess the European Parliament’s position on the other issues. This vote […]