Oncology Drug Review Process

2003 ◽  
Vol 1 (1) ◽  
pp. 109-113
Author(s):  
Ann T. Farrell ◽  
Richard Pazdur
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Drug Application ◽  
Surrogate Endpoint ◽  
Therapeutic Benefit ◽  
Favorable Effect ◽  
Priority Review ◽  
Marketing Approval ◽  
Life Threatening ◽  
A Priority

The U.S. Food and Drug Administration facilitates the development of drugs intended to treat cancer and other serious or life-threatening diseases. This article describes the new drug application (NDA) process, endpoints used in oncologic trials, and recent initiatives to expedite the review of drugs used to treat serious and life-threatening diseases. The Food and Drug Administration can grant either regular or accelerated marketing approval for oncology drugs. Regular approval is based on endpoints demonstrating that the drug provides a clinical benefit, such as longer life, enhanced quality of life, or a favorable effect on an established surrogate for longer or better life, such as long-term complete responses. Accelerated approval is based on a surrogate endpoint that is less well established but is reasonably likely to predict a longer or better life and can be granted for drugs that are intended to treat a serious or life-threatening illness and that provide meaningful therapeutic benefit to patients over existing therapies. The Agency classifies an NDA as either a priority or a standard application. Drugs that receive priority review are agents that appear to represent significant improvements over existing therapies. A priority NDA is reviewed by the Agency within 6 months; a standard review is accomplished within 10 months. The Agency communicates with sponsors throughout the drug development process, suggesting appropriate trial designs and meaningful endpoints.

Evaluation of Orphan Products by the U.S. Food and Drug Administration

1992 ◽  
Vol 8 (4) ◽  
pp. 647-657 ◽  
Author(s):  
Marlene E. Haffner ◽  
John V. Kelsey
Keyword(s):  
Drug Administration ◽  
Rare Diseases ◽  
Food And Drug Administration ◽  
Orphan Drugs ◽  
Marketing Approval ◽  
Drug Products ◽  
Governmental Agencies ◽  
Number Of Patients ◽  
Life Threatening ◽  
The U.S

AbstractOrphan drug products generally are used in treating or preventing rare diseases. The small number of patients available for study may create special problems in the evaluation of these products. This paper examines some of the special problems that are associated with the design and implementation of studies to evaluate the safety and efficacy of orphan drugs. The U.S. Food and Drug Administration (FDA) has not established special criteria for evaluating orphan drugs per se, but the FDA has been flexible in evaluating drug products that present special problems, especially when these products are for treatment of serious of life-threatening illnesses. The FDA and other U.S. governmental agencies also have taken steps to promote the development and availability of drugs for rare diseases, including making these products available to patients who are in need, even before the drugs have full FDA marketing approval.

scholarly journals Under-representation of racial minorities in prostate cancer studies submitted to the US Food and Drug Administration to support potential marketing approval, 1993-2013

Cancer ◽  
2014 ◽  
Vol 120 (19) ◽  
pp. 3025-3032 ◽  
Author(s):  
Michel D. Wissing ◽  
Paul G. Kluetz ◽  
Yang-Min Ning ◽  
Jonca Bull ◽  
Christine Merenda ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Racial Minorities ◽  
Marketing Approval ◽  
The Us ◽  
Cancer Studies

Present Status of Supplemental Application Submission in USFDA

2018 ◽  
Vol 9 (3) ◽  
Author(s):  
Verma S ◽  
Misri P ◽  
Yashwant . ◽  
Haque A
Keyword(s):  
United States ◽  
Drug Administration ◽  
Present Status ◽  
Drug Product ◽  
Food And Drug Administration ◽  
Drug Application ◽  
The United States ◽  
United States Food ◽  
States Food ◽  
Year 2000

Objective: In order to reach to the market, a drug product has to undergo various phases of scrutiny assuring its quality, safety and efficacy. Once the experimental drug promises its safety, efficacy and quality it is permitted to be marketed by the regulator. The drug is still present under surveillance for possibility of any adverse drug reaction or any other alteration or a new indication. If any modification is to be done, then the applicant/sponsor needs to file a supplemental application. This article provides information about present status of supplemental new drug application submitted and approved to the United States food and drug administration. Materials and methods: The data have been archived from the official website of United States food and drug administration comprising all the applications approved by this regulatory agency from the year 2000 to 2016. The data has been segregated and statistically analyzed using ANOVA on the basis of different categories of approved applications. Results: As per the analysis, from the year 2000 to 2016, a total of 69,585 applications was filed to USFDA, amongst which 9499 were original applications and 60,086 were supplemental applications.

Abuse-deterrent Opioid Formulations

2018 ◽  
Vol 128 (5) ◽  
pp. 1015-1026 ◽  
Author(s):  
Ronald S. Litman ◽  
Olivia H. Pagán ◽  
Theodore J. Cicero
Keyword(s):  
Intravenous Injection ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Opioid Abuse ◽  
Marketing Approval ◽  
Opioid Overdose ◽  
Insufficient Evidence ◽  
Fda Approval ◽  
The U.S

Abstract Abuse-deterrent opioid formulations have been suggested as one way to decrease the abuse, addiction, and overdose of orally prescribed opioids. Ten oral opioid formulations have received abuse-deterrent labeling by the U.S. Food and Drug Administration (FDA). Their properties consist of physical and/or chemical means by which the pills resist manipulation and create a barrier to unintended administration, such as chewing, nasal snorting, smoking, and intravenous injection. In this review, we describe the mechanisms of abuse-deterrent technology, the types of premarketing studies required for FDA approval, the pharmacology of the currently approved abuse-deterrent opioid formulations, and the evidence for and against their influence on opioid abuse. We conclude that there is currently insufficient evidence to indicate that the availability of abuse-deterrent opioid formulations has altered the trajectory of opioid overdose and addiction; however, postmarketing studies are in their infancy, and novel deterrent formulations are continually being developed and submitted for marketing approval.

Docetaxel-induced cardiac-respiratory arrest in a patient with chronic atrial fibrillation

2017 ◽  
Vol 24 (7) ◽  
pp. 531-536 ◽  
Author(s):  
Mostaqul Huq ◽  
Tracie M Balvanz ◽  
Scott Mambourg
Keyword(s):  
Prostate Cancer ◽  
Atrial Fibrillation ◽  
Drug Administration ◽  
Case Reports ◽  
Food And Drug Administration ◽  
Chronic Atrial Fibrillation ◽  
Respiratory Arrest ◽  
Life Threatening ◽  
Cancer Types ◽  
Hispanic Male

Docetaxel has been approved by the Food and Drug Administration for the treatment of many cancer types, including breast cancer, head and neck cancer, lung cancer, and prostate cancer. Many severe to life-threatening side effects (Grades 3–5) of docetaxel have been reported in clinical trials, case reports, and Food and Drug Administration Adverse Events Reporting System. These include anaphylactic reactions, febrile neutropenia, fluid retention, acute respiratory distress, pleural effusion, pneumonia, and peripheral neuropathy. There were fewer cardiac toxicities reported for docetaxel as compared to paclitaxel, which were less severe. In this report, we present a clinical case of docetaxel-induced cardiac-respiratory arrest in a 62-year-old Hispanic male patient with stable chronic atrial fibrillation, who has been recently diagnosed with metastatic prostate cancer. The cardiac event developed within 15 min of docetaxel infusion during the second cycle of chemotherapy despite using recommended premedication with corticosteroids.

scholarly journals Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings

PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0252155
Author(s):  
Rishad Khan ◽  
Karam Elsolh ◽  
Nikko Gimpaya ◽  
Michael A. Scaffidi ◽  
Rishi Bansal ◽  
...  
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Conflicts Of Interest ◽  
Food And Drug Administration ◽  
Drug Application ◽  
The United States ◽  
Primary Study ◽  
Drug Advisory Committee ◽  
Univariate Analyses ◽  
Over Time

Introduction The United States Food and Drug Administration (FDA) Gastrointestinal Drug Advisory Committee (GIDAC) is involved in gastrointestinal drug application reviews. Characteristics and conflicts of interest (COI) in GIDAC meetings are not well described. This study analyzed FDA GIDAC meetings and characteristics that predict recommendations. Methods In this cross-sectional study, all publicly available GIDAC meetings where proposed medications were voted on were included. Data were collected regarding indications, medication sponsor, primary efficacy studies, and voting member characteristics (e.g. committee membership, COI). Univariate analyses were conducted at per-meeting and per-vote levels to assess for predictors of committee recommendation and individual votes respectively. Results Thirty-four meetings with 476 individual votes from 1998–2018 were included. Twenty-three (68%) proposals were recommended for approval and 25 (74%) received FDA approval. Most proposals involved >1 primary study (n = 27, 79%). At least one voting member had a COI in 24 (71%) of 34 meetings. Twelve (35%) meetings had at least one sponsor COI. Among 476 individual votes, 74 (15.5%) involved a COI, with 33 (6.9%) sponsor COI. COI decreased significantly over time, with fewer COI in 2006–2010, 2011–2015, and 2016–2020 compared to 1996–2000 and 2001–2005 (p<0.01). There were no significant associations between pre-defined predictors, including COI, and committee level recommendations or individual votes (p>0.05 for all univariate analyses). Conclusions The GIDAC reviewed 34 proposals from 1998–2018. The majority were recommended for approval and later approved by the FDA, highlighting the GIDAC’s prominence in the regulatory process. COI are present among GIDAC panelists but decreasing over time and not associated with recommendations.

Science in the marketplace: Acnotabs and the Food and Drug Administration

1993 ◽  
Vol 2 (1) ◽  
pp. 59-70 ◽  
Author(s):  
Rima D. Apple
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Skin Condition ◽  
The Us ◽  
Threatening Condition ◽  
Life Threatening ◽  
Medical Theory ◽  
Scientific Claims

Though acne is not a life-threatening condition, it is a highly emotionally charged one, particularly for teenagers. In the early 1960s, when the Pannett Company used medical and scientific claims to convince adolescents to purchase their product, Acnotabs, their amazing advertising claims attracted the attention of the US Food and Drug Administration. Typically the Agency seized a product it considered mislabelled in terms of its ingredients or its efficacy; and most companies, not willing to face a potentially expensive fight, did not object to the action. In effect, they allowed the courts to issue a condernnation order by default. The Pannett Company, however, resisted the FDA's seizure and decided to present their case for Acnotabs in court. The Company insisted that their tests had demonstrated the usefulness of Acnotabs in treating the skin condition. The FDA claimed that there was no evidence for the effectiveness of Acnotabs and, moreover, that scientific and medical theory denied that the ingredients in Acnotabs would cure acne. The records of this case provide a unique demonstration of how a layperson, a judge, evaluated competing definitions of science and scientific proof.

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