The Orange Book: the Food and Drug Administration's advice on therapeutic equivalence.

Am Pharm

Office of Generic Drugs, Food and Drug Administration, Rockville, MD 20857.

Published: July 1990

Download full-text PDF

Source
http://dx.doi.org/10.1016/s0160-3450(16)33557-7DOI Listing

Publication Analysis

Top Keywords

orange book
4
book food
4
food drug
4
drug administration's
4
administration's advice
4
advice therapeutic
4
therapeutic equivalence
4
orange
1
food
1
drug
1

Similar Publications

Background: Previous literature has highlighted the complexity of supporting an acutely unwell child and the unnecessary use of services by parents/carers. The Little Orange Book (LOB) was developed as an information resource for parents/carers of young children to assist in managing symptoms of childhood illness and to encourage the appropriate use of healthcare services.

Objectives: This study aimed to understand parent/carer views and experiences using the Little Orange Book.

View Article and Find Full Text PDF

Importance: Neoadjuvant therapy (NT) is an increasingly used treatment strategy for patients with localized pancreatic ductal adenocarcinoma (PDAC). Little research has been conducted on cancer care delivery during NT, and the standards for optimal delivery of NT have not been defined.

Objective: To develop consensus best practices for delivering NT to patients with localized PDAC.

View Article and Find Full Text PDF

Barriers to Medication Adherence in People Living With Epilepsy.

Neurol Clin Pract

February 2025

Department of Neurology (MAD, HA, JDB, SFZ, LM), Massachusetts General Hospital, Harvard Medical School, Boston, MA; Behavioral Medicine and Clinical Psychology (ACM), Cincinnati Children's Hospital Medical Center; University of Cincinnati-College of Medicine (ACM), Cincinnati, OH; Epilepsy Foundation (JV, AK, KF, BEF), Bowie, MD; Department of Neurology (SWB), Keck Medicine of University of Southern California, Los Angeles, CA; Department of Neurology (STH), Barrow Neurological Institute, Phoenix, AZ; Department of Neurology (DMF), UC Gardner Neuroscience Institute, Cincinnati, OH; Neurology Department (WHT), Penn State Health Children's, Hershey, PA; Neurology Department (DS), UT Southwestern Medical Center Children's Health, Dallas, TX; CHOC Neuroscience Center (DJP), Children's Hospital of Orange County, Orange, CA; Department of Neurology (JP), University of Colorado School of Medicine, Denver, CO; and Department of Pediatrics (JB), Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.

Background And Objectives: Epilepsy affects approximately 1.2% of the US population, resulting in 3.4 million Americans with active epilepsy.

View Article and Find Full Text PDF

Importance: In December 2023, the Biden-Harris Administration released a proposed framework for exercising government march-in rights (effectively granting compulsory licenses for those patents to generic drug makers) under the Bayh-Dole Act on patents on taxpayer-funded drugs, which has renewed questions about whether march-in rights could promote cost savings through generic competition or harm pharmaceutical innovation.

Objectives: To determine the feasibility of using march-in rights to remove patent barriers to generic competition.

Design, Setting, And Participants: This cross-sectional study examined government funding information from multiple sources for patents listed in the Food and Drug Administration (FDA) Orange Book from 1985 to 2023.

View Article and Find Full Text PDF

Purpose: Healthcare providers often need to explore alternative options for patients who are unable to swallow whole tablets or capsules. Many newly approved immediate-release (IR) solid oral drugs carry a general "do-not-crush" warning or similar statements in their labeling without any explanations. A 2021 publication by Uttaro et al.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!