Articles for “FDA and EPA”

February 22, 2011 by Elizabeth Parker|FDA and EPA

The Food and Drug Administration has posted revised versions of the following Import Alerts on the detention without physical examination of:

CPSC Lists Voluntary Recalls

February 18, 2011 by Barbara Chaves|FDA and EPA

The Consumer Product Safety Commission has published notice of the following voluntary recalls:

CPSC Announces Open Meetings with Industry Stakeholders

February 18, 2011 by Kelly Sly|FDA and EPA

The Consumer Product Safety Commission has updated its list of meetings between CPSC and industry stakeholders that are open to the public, unless otherwise stated:

Revised FDA Import Alerts

February 18, 2011 by Elizabeth Parker|FDA and EPA

The Food and Drug Administration has posted revised versions of the following Import Alerts on the detention without physical examination of:

CPSC Publishes FY 2010 Service Contract Actions

February 17, 2011 by Kelly Sly|FDA and EPA

The Consumer Product Safety Commission is announcing the availability of its service contract inventory for fiscal year 2010, pursuant to the Consolidated Appropriations Act. This inventory provides information on service contract actions over $25,000 that CPSC made in FY 2010. (See ITT's Online Archives or 02/08/11 news, 11020810, for BP summary of CPSC's vote to publish this inventory.)

Revised FDA Import Alerts

February 17, 2011 by Elizabeth Parker|FDA and EPA

The Food and Drug Administration has posted revised versions of the following Import Alerts on the detention without physical examination of:

CPSC Proposes to Exempt Powder Forms of 2 Drugs from Child-Resistant Packaging

February 16, 2011 by Kelly Sly|FDA and EPA

The Consumer Product Safety Commission has issued a proposed rule to amend its child-resistant packaging requirements to exempt powder formulations of two oral prescription drugs, colesevelam hydrochloride (for adults with type 2 diabetes mellitus) and sevelamer carbonate (for chronic kidney disease patients on dialysis), on the basis that child-resistant packaging is not needed to protect young children from serious injury or illness. Comments are due by May 2, 2011.

CPSC Posts Details of FY 2012 Budget Request, Commissioner Statements

February 16, 2011 by Barbara Chaves|FDA and EPA

The Consumer Product Safety Commission has posted details of its fiscal year 2012 budget request of $122 million, a 3.2% increase over the continuing resolution 2011 fiscal year. It has also posted a joint statement by Chairman Tenenbaum and Commissioners Adler and Moore and a separate statement by Commissioner Nord.

Revised FDA Import Alerts

February 16, 2011 by Elizabeth Parker|FDA and EPA

The Food and Drug Administration has posted revised versions of the following Import Alerts on the detention without physical examination of:

FDA Exempts Medical Device Data Systems from Premarket Notifications

February 15, 2011 by Kelly Sly|FDA and EPA

The Food and Drug Administration is issuing a final rule, effective April 18, 2011, to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. FDA is exempting MDDSs from the premarket notification requirements.