WorldCat Identities

United States Food and Drug Administration Office of the Commissioner

Overview
Works: 15 works in 20 publications in 1 language and 3,585 library holdings
Genres: Directories 
Classifications: KF3885,
Publication Timeline
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Most widely held works by United States
Report by the Commissioner of Food and Drugs on findings and recommendations of the Review Panel on New Drug Regulation by United States( Book )

1 edition published in 1978 in English and held by 5 WorldCat member libraries worldwide

[Background memos and letters relating to Dr. Kennedy's letter to all Bureau of Drugs employees.] by United States( Book )

1 edition published in 1977 in English and held by 2 WorldCat member libraries worldwide

Guidance emergency use authorization of medical products( )

1 edition published in 2007 in English and held by 0 WorldCat member libraries worldwide

"This guidance explains FDA's policies for authorizing the emergency use of medical products under section 564 of the Federal Food, Drug, and Cosmetic Act (FD & C Act) (21 U.S.C. 360bbb-3), which was amended by the Project BioShield Act of 2004 (Public Law 108-276).2 Section 564 permits the FDA Commissioner to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security. The Emergency Use Authorization (EUA) authority recently granted by Congress allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological, and nuclear agents that may be used to attack the American people or the U.S. armed forces. Under section 564, the FDA Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved, and available alternatives. The document is intended to inform industry, government agencies, and FDA staff of the Agency's general recommendations and procedures for issuance of EUAs.3 FDA expects that requests for consideration for an EUA would be submitted by government agencies (e.g., the Department of Health and Human Services or the Department of Defense (DoD)) or private entities. FDA may seek additional data and information on a case-by-case basis to ensure that the statutory criteria for issuance of an EUA are met."
Guidance for industry Prescription Drug Marketing Act (PDMA) requirements, questions and answers( )

1 edition published in 2006 in English and held by 0 WorldCat member libraries worldwide

Guidance for industry providing regulatory submissions in electronic format, drug establishment registration and drug listing( )

2 editions published between 2008 and 2009 in English and held by 0 WorldCat member libraries worldwide

Guidance for clinical investigators, sponsors, and IRBs adverse event reporting to IRBs : improving human subject protection( )

1 edition published in 2009 in English and held by 0 WorldCat member libraries worldwide

Guidance for industry IRB review of stand-alone HIPAA authorizations under FDA regulations( )

1 edition published in 2003 in English and held by 0 WorldCat member libraries worldwide

Guidance for industry standards for securing the drug supply chain : standardized numerical indentification for prescription drug packages( )

1 edition published in 2009 in English and held by 0 WorldCat member libraries worldwide

Guidance for institutional review boards (IRBs) frequently asked questions, IRB registration( )

1 edition published in 2009 in English and held by 0 WorldCat member libraries worldwide

Guidance for industry computerized systems used in clinical investigations( )

1 edition published in 2007 in English and held by 0 WorldCat member libraries worldwide

 
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Languages
English (20)