The Federal Register

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; MedWatch: Food

Wed, Dec 7 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``MedWatch: Food and Drug Administration Medical Products Reporting Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop; Amendment of

Wed, Dec 7 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an amendment to the notice of public workshop on FDA clinical trial statutory and regulatory requirements. This workshop was announced in the Federal Register of September 21, 2005 (70 FR 55405). The amendment is made to reflect a change in the Location portion of the document. There are no other changes.

Risk Management, Corrective and Preventive Actions, and Training: An Educational Forum; Public Workshop

Wed, Dec 7 2005 11:00:00 GMT

The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Region, Dallas District Office, in collaboration with the FDA Medical Device Industry Coalition (FMDIC) is announcing a public workshop entitled ``Risk Management, Corrective and Preventive Actions, and Training: An Educational Forum.'' This public workshop is intended to provide information about FDA's medical device quality systems regulation (QSR) to regulated industry, particularly small businesses.

Date and Time: The public workshop will be held on April 28, 2006, from 8 a.m. to 5 p.m.

Location: The public workshop will be held at The Westin City Center, 650 North Pearl St., Dallas, TX 75201. Directions to the facility are available at the FMDIC Web site at http://www.fmdic.org/.

Contact Person: David Arvelo or Cassandra Davis, Food and Drug Administration, 4040 North Central Expres