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ORA FOIA Electronic Reading Room. Some third parties query the FDA and publish a listing of Form FDA 483s issued since 2000. [19] As of 21-Nov-2009, the FDA is seeking input from the public "on whether inspection reports should be re-designed to separate out a summary or key findings page that could be made available to the public quickly."
A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act. [ 1] While the FDA generally determines violations through its own inspections, they can also issue one based on evidence from state personnel. [ 2] The FDA considers a warning letter informal and advisory.
The Freedom of Information Act (FOIA / ˈ f ɔɪ j ə / FOY-yə), 5 U.S.C. § 552, is the United States federal freedom of information law that requires the full or partial disclosure of previously unreleased or uncirculated information and documents controlled by the U.S. government upon request. The act defines agency records subject to ...
United States Department of State. / 38.89417°N 77.04833°W / 38.89417; -77.04833. The United States Department of State ( DOS ), [ 3] or simply the State Department, [ 4] is an executive department of the U.S. federal government responsible for the country's foreign policy and relations. Equivalent to the ministry of foreign affairs ...
The history of the FDA can be traced to the latter part of the 19th century and the U.S. Department of Agriculture's Division of Chemistry (later Bureau of Chemistry). Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market.
Complete Response Letter. In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will ...
The Holder Memo is part of series of policy memos on how federal agencies should apply FOIA exemptions. Beginning in 1977 with Attorney General Griffin Bell, and continued by Attorney General William French Smith in 1981 and Attorney General Janet Reno in 1993, U.S. Department of Justice (DOJ) has announced how the executive branch should approach FOIA, its application, and DOJ's defense of ...
For Official Use Only (FOUO) was one of five categories of the Dissemination Limiting Marker (DLM) defined by the Australian Government Information Security Management Guidelines. [ 4] The guidelines state that FOUO should only be used on unclassified information, when its compromise may cause limited damage to national security, Australian ...