New Drug Approval : FDA Needs To Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints.

Drug approval : access to experimental drugs for severely ill patients /
by: Randall, Blanchard
Published: (1989)

The Food and Drug Administration's process for approving new drugs : report /
Published: (1980)

Prescription Drugs : FDA's Oversight of the Promotion of Drugs for Off-Label Uses.
Published: (2008)

New drug approval process /
Published: (1993)

FDA's drug approval process : up to the challenge? : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, first session, on examining Food and Drug Administration's (FDA) drug approval process, focusing on FDA's drug approval process after a sponsor demonstrates that their benefits outweigh their risks for a specific population and use, and that the drug meet [as printed] meets standards for safety and efficacy, March 1, 2005.
Published: (2005)

FDA's drug approval process : up to the challenge? : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, first session, on examining Food and Drug Administration's (FDA) drug approval process, focusing on FDA's drug approval process after a sponsor demonstrates that their benefits outweigh their risks for a specific population and use, and that the drug meet [as printed] meets standards for safety and efficacy, March 1, 2005.
Published: (2005)

Drug Safety : Improvement Needed in FDA's Postmarket Decision-Making and Oversight Process.
Published: (2006)

New drug approval process : the global challenge /
Published: (2000)

Drugs@FDA.

Food and Drug Administration : Approval and Oversight of the Drug Mifeprex.
Published: (2008)

Preparing for FDA pre-approval inspections /
Published: (1999)

Prescription drugs : many factors affected FDA's approval of selected "pipeline" drugs : report to congressional requesters.
Published: (2000)

FDA's generic drug approval process : hearings before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred First Congress, first session.
Published: (1989)

Regulation of new drug R. & D. by the Food and Drug Administration, 1974 : joint hearings before the Subcommittee on Health of the Committee on Labor and Public Welfare, and the Subcommittee on Administrative Practice and Procedure of the Committee on the Judiciary, United States Senate, Ninety-third Congress, second session ... September 25 and 27, 1974.
Published: (1974)

FDA's generic drug approval process : hearings before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred First Congress, first session.
Published: (1989)

FDA drug bulletin.
Published: (1971)

Prescription drugs : FDA oversight of direct-to-consumer advertising has limitations.
Published: (2002)

Prescription drugs : improvements needed in FDA's oversight of direct-to-consumer advertising : report to congressional requesters.
Published: (2006)

Prescription drugs : improvements needed in FDA's oversight of direct-to consumer advertising : report to congressional requesters /
Published: (2006)

Drug lag : Federal Government decision making /
by: Ricardo-Campbell, Rita
Published: (1976)

FDA and the drug development process : how the agency ensures that drugs are safe and effective.
Published: (2002)

Drug compounding : clear authority and more reliable data needed to strengthen FDA oversight : report to congressional requesters.
Published: (2013)

Drug safety : improvement needed in FDA's postmarket decision-making and oversight process : report to congressional requesters.
Published: (2006)

The Food and Drug Administration (FDA) /
Published: (2003)

The regulation of new drugs by the Food and Drug Administration : the new drug review process : hearings before a subcommittee of the Committee on Government Operations, House of Representatives, Ninety-seventh Congress, second session, August 3 and 4, 1982.
Published: (1982)

Department of Health and Human Services, Food and Drug Administration : applications for FDA approval to market a new drug : patent submission and listing requirements and application of a 30-month stays on approval of abbreviated new drug applications certifying that a patent claiming a drug is invalid or will not be infringed /
Published: (2003)

FDA's review process for new drug applications : a management review.
Published: (2003)

Drug safety : FDA has begun efforts to enhance postmarket safety, but additional actions are needed : report to the Ranking Member, Committee on Finance, U.S. Senate.
Published: (2009)

The Food and Drug Administration's process for approving new drugs : oversight : hearings before the Subcommittee on Science, Research, and Technology of the Committee on Science and Technology, U.S. House of Representatives, Ninety-sixth Congress, first session, June 19, 21, July 11, 1979.
Published: (1979)

Drug safety : FDA needs to further address shortcomings in its postmarket decision-making process : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives /
by: Crosse, Marcia
Published: (2007)

Drug safety : preliminary findings suggest weaknesses in FDA's program for inspecting foreign drug manufacturers : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives /
by: Crosse, Marcia
Published: (2007)

Prescription drugs : FDA's oversight of the promotion of drugs for off-label uses : report to the Ranking Member, Committee on Finance, U.S. Senate.
Published: (2008)

Food and Drug Administration : approval and oversight of the drug Mifeprex : report to congressional requesters.
Published: (2008)

Drug Listing Act of 1971.
Published: (1971)

Drug manufacturing : FDA should fully assess its efforts to encourage innovation : report to congressional committees /
Published: (2023)

Drug Safety : FDA Has Begun Efforts To Enhance Postmarket Safety, but Additional Actions Are Needed.
Published: (2009)