Compounded Drugs

Compounded Drugs

Date: May 23, 2013
Creator: Glassgold, Judith M.
Description: This report provides background information on compounded drugs (CDs) and nontraditional compounding pharmacies relevant to policy discussions. This includes an overview of the 2012 fungal meningitis outbreak; recent recalls of compounded drugs; definitions of traditional compounding and nontraditional compounding; information on the CDs produced and by whom; information on the demand for nontraditional compounding, including the role of shortages of sterile injectable drugs, hospital outsourcing, and patient and provider demand; and information on adverse events involving compounded drugs.
Contributing Partner: UNT Libraries Government Documents Department
Authorized Generic Pharmaceuticals: Effects on Innovation

Authorized Generic Pharmaceuticals: Effects on Innovation

Date: August 8, 2006
Creator: Thomas, John R
Description: The practice of “authorized generics” has recently been the subject of considerable attention by the pharmaceutical industry, regulators, and members of Congress alike. An “authorized generic”–sometimes termed a “branded,” “flanking,” or “pseudo” generic–is a pharmaceutical that is marketed by or on behalf of a brand name drug company, but is sold under a generic name. Although the availability of an additional competitor in the generic drug market would appear to be favorable to consumers, authorized generics have nonetheless proven controversial. Some observers believe that authorized generics potentially discourage independent generic firms both from challenging drug patents and from selling their own products.
Contributing Partner: UNT Libraries Government Documents Department
The FDA 2009 Budget Request

The FDA 2009 Budget Request

Date: May 19, 2008
Creator: Johnson, Judith A.; Lister, Sarah A.; Porter, Donna V.; Smith, Pamela W.; Thaul, Susan & Williams, Erin D.
Description: The Administration's FY2009 budget request of $2.4 billion for the Food and Drug Administration (FDA) would provide a 5.7% increase ($130 million) over FY2008. User fees would make up about 26% of the total amount requested and would account for 61% of the proposed increase. Budget documents indicate that the additional funding would provide for expanded activities to ensure the safety of foods and drugs, as well as to accelerate the availability of new medical products. About half of the requested increase would be used for cost-of-living pay increases, as opposed to new program activities.
Contributing Partner: UNT Libraries Government Documents Department
Prescription Drug Importation and Internet Sales: A Legal Overview

Prescription Drug Importation and Internet Sales: A Legal Overview

Date: January 8, 2004
Creator: Feder, Jody
Description: None
Contributing Partner: UNT Libraries Government Documents Department
Follow-On Biologics: Intellectual Property and Innovation Issues

Follow-On Biologics: Intellectual Property and Innovation Issues

Date: August 3, 2009
Creator: Schacht, Wendy H. & Thomas, John R.
Description: This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of the report introduces innovation policy issues pertaining to follow-on biologics.
Contributing Partner: UNT Libraries Government Documents Department
FDA Regulation of Follow-On Biologics

FDA Regulation of Follow-On Biologics

Date: February 24, 2009
Creator: Johnson, Judith A.
Description: This report provides a brief introduction to the relevant law regarding follow-on biologics, the regulatory framework at the FDA, the scientific challenges for the FDA in considering the approval of follow-on biologics, and a description of the proposed legislation.
Contributing Partner: UNT Libraries Government Documents Department
The FDA FY2009 Budget

The FDA FY2009 Budget

Date: August 25, 2008
Creator: Johnson, Judith A.; Lister, Sarah A. & Porter, Donna V.
Description: This report discusses the Food and Drug Administration's (FDA's) FY2009 budget request of $2.676 billion that would provide a 17.9% increase ($406 million) over FY2008. It includes an overview and breakdowns for specific programs: Foods Program, Human Drugs Program, Biologics program, Animal Drugs and Feed Program, and the Devices and Radiological Health Program.
Contributing Partner: UNT Libraries Government Documents Department
Pharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation

Pharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation

Date: November 4, 2008
Creator: Thomas, John R.
Description: This report introduces and analyzes innovation policy issues concerning pharmaceutical patent litigation settlements, including pharmaceutical patent litigation procedures under the Hatch-Waxman Act, the concept of reverse payment settlements, the status of reverse payment settlements under the antitrust laws, and congressional issues and alternatives.
Contributing Partner: UNT Libraries Government Documents Department
Patents and Drug Importation

Patents and Drug Importation

Date: June 1, 2007
Creator: Thomas, John R.
Description: This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.
Contributing Partner: UNT Libraries Government Documents Department
Patents and Drug Importation

Patents and Drug Importation

Date: May 25, 2004
Creator: Thomas, John R.
Description: This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.
Contributing Partner: UNT Libraries Government Documents Department
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