Articles for “FDA and EPA”

EPA Announces PMNs, TME Applications Received for New Chemicals, Etc.

February 1, 2012 by Marie Rapport|FDA and EPA

As required by the Toxic Substances Control Act, the Environmental Protection Agency has issued "receipt and status" reports on the premanufacture notices (PMNs), applications for test marketing exemptions (TMEs), and notices of commencement to manufacture (NOCs), that it has received from those intending to manufacture (which includes import) a new chemical (i.e., a chemical not on the TSCA Inventory). EPA has issued three notices on these reports, for the periods of November 1, 2011 to December 2, 2011 (here), December 6, 2011 to December 16, 2011 (here), and December 19 to December 30, 2011 (here). Comments identified by the specific PMN number or TME number are due by March 2, 2012.

New and Revised FDA Import Alerts on Jan 31

February 1, 2012 by Jewel Hoffman|FDA and EPA

On January 31, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Posts Report on Making Compliance, Enforcement Data Accessible

February 1, 2012 by Cindy Arevalo|FDA and EPA

The Food and Drug Administration is announcing the availability of a report entitled ‘‘Food and Drug Administration Transparency Initiative: Exploratory Program to Increase Access to the Agency’s Compliance and Enforcement Data,’’ as part of its Transparency Initiative. This report includes eight initiatives adopted by the FDA Commissioner to explore avenues for making FDA’s publicly available compliance and enforcement data more accessible and user-friendly. Based on recommendations of the Transparency Task Force, the Commissioner is adopting all eight of the draft proposals published in October 2011 as initiatives the FDA will explore, thereby committing the FDA to investigating numerous avenues for increasing the transparency and public accessibility of its compliance and enforcement data.

New and Revised FDA Import Alerts on Jan 30

January 31, 2012 by Jewel Hoffman|FDA and EPA

On January 30, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Weekly Enforcement Report on Status of Recalls & Field Corrections

January 31, 2012 by Marie Rapport|FDA and EPA

The Food and Drug Administration issued its weekly Enforcement Report for January 25, 2012 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

New and Revised FDA Import Alerts on Jan 27

January 30, 2012 by Jewel Hoffman|FDA and EPA

On January 27, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts on Jan 26

January 27, 2012 by Jewel Hoffman|FDA and EPA

On January 26, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts on Jan 25

January 26, 2012 by Jewel Hoffman|FDA and EPA

On January 25, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts on Jan 24

January 25, 2012 by Jewel Hoffman|FDA and EPA

On January 24, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Issues Guidance on Drug & Biological Product Promotional Labeling

January 25, 2012 by Cindy Arevalo|FDA and EPA

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling." The guidance is intended to clarify for applicants the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertising for prescription human and animal drugs and biological products. This guidance finalizes the draft guidance published in January 1999. Comments may be submitted at any time.