Drug Product Approval in the United States and International Harmonization

2017 ◽  
pp. 1049-1077
Author(s):  
L. Wu ◽  
H. Smith ◽  
H. Zheng ◽  
L.X. Yu
Keyword(s):  
United States ◽  
Drug Product ◽  
The United States ◽  
Product Approval ◽  
International Harmonization

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 Materials and methods: The data have been archived from the official website of United States food and drug administration comprising all the applications approved by this regulatory agency from the year 2000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.

How Often are Orphan Drugs Orphaned by the Thermochemical Community?

2020 ◽  
Vol 27 (1) ◽  
pp. 23-31 ◽  
Author(s):  
Kathleen F. Edwards ◽  
Joel F. Liebman
Keyword(s):  
United States ◽  
Metabolic Disease ◽  
Orphan Drug ◽  
Drug Product ◽  
Orphan Drugs ◽  
The United States ◽  
Drug Products ◽  
Chemical Structures ◽  
Disease Condition ◽  
The U.S

Orphan drug products (e.g. drugs and biologics) in the United States are those that treat people with rare chronic diseases, often cancer or metabolic disease. The rare disease condition being treated by these orphan drugs must serve a patient population of less than 200,000 people in the U.S. in order to earn the orphan drug product title. Just as the disease conditions are seen as “orphans,” so, we assert is the thermochemical understanding of the drugs themselves in terms of the chemical structures that define those drugs. This article illustrates this orphan thermochemical status for a recent series of orphan drugs.

Public Policy Considerations in the Pricing of Prescription Drugs in the United States

1974 ◽  
Vol 4 (1) ◽  
pp. 171-179 ◽  
Author(s):  
T. Donald Rucker
Keyword(s):  
United States ◽  
Prescription Drugs ◽  
Drug Product ◽  
Economic Value ◽  
Economic Cost ◽  
The United States ◽  
Third Party ◽  
Accounting System ◽  
Consumer Sovereignty ◽  
Cost Accounting System

The economic value of prescribed drugs consumed in the United States probably reached $10 billion in 1973. Public interest in pricing practices is traced to the involuntary nature of patient illness in general and prescribing in particular, the intrinsic attributes of drug therapy, and the growing role of third-party programs in determining reimbursement for prescription items. Drug product pricing is criticized because of the large proportion of sales revenue consumed by indirect expenses. Nine branded products are cited where the median value of revenue consumed by indirect expenses is 91 per cent. Pricing problems related to increases in active ingredients, quantities sold, and package size are also examined. Pricing at the dispensing level is assessed in terms of its relationship to the true economic cost of this function. Significant imperfections are noted and a uniform cost-accounting system for pharmacies is recommended. The issue of prescription price posting is reviewed in some detail, and it is suggested that the posting of a unique dispensing fee in each pharmacy would optimize consumer sovereignty.

International harmonization of models for selecting less toxic chemical alternatives: Effect of regulatory disparities in the United States and Europe

2012 ◽  
Vol 8 (4) ◽  
pp. 723-730 ◽  
Author(s):  
Carl W Lam ◽  
Muskilda P Aguirre ◽  
Karsten Schischke ◽  
Nils F Nissen ◽  
Oladele A Ogunseitan ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
Toxic Chemical ◽  
International Harmonization

scholarly journals Anesthetic and Analgesic Drug Products Advisory Committee Activity and Decisions in the Opioid-crisis Era

2020 ◽  
Vol 133 (4) ◽  
pp. 740-749 ◽  
Author(s):  
Ronald S. Litman
Keyword(s):  
United States ◽  
Advisory Committee ◽  
Drug Administration ◽  
Drug Product ◽  
Food And Drug Administration ◽  
The United States ◽  
New Drugs ◽  
Analgesic Drug ◽  
Drug Products ◽  
United States Food

The United States Food and Drug Administration is tasked with ensuring the efficacy and safety of medications marketed in the United States. One of their primary responsibilities is to approve the entry of new drugs into the marketplace, based on the drug’s perceived benefit–risk relationship. The Anesthetic and Analgesic Drug Product Advisory Committee is composed of experts in anesthesiology, pain management, and biostatistics, as well as consumer and industry representatives, who meet several times annually to review new anesthetic-related drugs, those seeking new indications, and nearly every opioid-related application for approval. The following report describes noteworthy activities of this committee since 2017, as it has grappled, along with the Food and Drug Administration, to balance the benefit–risk relationships for individual patients along with the overarching public health implications of bringing additional opioids to market. All anesthesia advisory committee meetings since 2017 will be described, and six will be highlighted, each with representative considerations for potential new opioid formulations or local anesthetics.

scholarly journals Mobile Alert and Warning in the United States and Japan: Confronting the Challenges of International Harmonization

2021 ◽  
Author(s):  
Hamilton Bean ◽  
Ana Maria Cruz ◽  
Mika Shimizu ◽  
Keri K. Stephens ◽  
Matthew McGlone ◽  
...  
Keyword(s):  
United States ◽  
Mobile Device ◽  
Disaster Risk Reduction ◽  
The United States ◽  
Disaster Risk ◽  
Warning Systems ◽  
International Harmonization ◽  
Global Partnership ◽  
Expert Workshop ◽  
Global Stakeholders

AbstractA U.S.-Japan expert workshop on mobile alert and warning was held online 8–10 September 2021. Funded by the Japan Foundation’s Center for Global Partnership (CGP) and responding to the Sendai Framework for Disaster Risk Reduction 2015–2030, the workshop compared U.S. and Japanese mobile alert and warning contexts, systems, policies, and messages to investigate possibilities for international harmonization of mobile device-based early warning. The workshop’s sessions revealed two interrelated issues that repeatedly surfaced among workshop participants: culture and policy. The workshop illuminated several possibilities and problems confronting U.S., Japanese, and global stakeholders as they develop, deploy, and seek to improve the effectiveness of mobile alert and warning systems and messages.

scholarly journals The legalization of cannabinoid products and standardizing cannabis-drug development in the United States: a brief report

2020 ◽  
Vol 22 (3) ◽  
pp. 289-293
Keyword(s):  
Public Health ◽  
United States ◽  
Drug Development ◽  
Drug Approval ◽  
The United States ◽  
Product Approval ◽  
The Public ◽  
Market Approval ◽  
Recent Advances

This brief report covers recent advances in cannabis and cannabinoid regulation and drug approval. The popularity of cannabis and cannabinoid products continues to rise, and these products are available for the majority of the population in the United States to purchase as easily as alcohol. Although many states have approved programs and research licenses, these activities and products all remain federally illegal. The solution may be for the United States to offer multiple pathways for product approval that adapt to the diversity of the products and the needs of the consumer. Multiple pathways for market approval would protect public health, whether the public is using cannabis and cannabinoids as a medicine, a wellness product, or as a recreational substance.

scholarly journals Agricultural Biotechnology and the "Early-Working" Exemptions Under the Patent Act

2015 ◽  
pp. 765
Author(s):  
Martin Phillipson
Keyword(s):  
United States ◽  
Research And Development ◽  
Early Development ◽  
Market Entry ◽  
Agricultural Biotechnology ◽  
The United States ◽  
Regulatory Approval ◽  
Legal Issues ◽  
Product Approval ◽  
Patent Expiry

The author explores the availability to genericmanufacturers of two research exemptions under the Canadian <i>Patent Act</i>.  In order to expedite later market entry, processes of research and development and federal product approval are often initiated prior to patent expiry. The question arises of when these "early-working" endeavours will violate the protection offered hy a patent. The "research exemption " has been interpreted narrowly, and may only be of limited use to potential manufacturers engaging in early development of protected products. However, the "regulatory approval exemption" has been given a wider interpretation, both in Canada and the United States, and it is likely that processes related to regulatory approval will not as readily be considered as patent infringing. Finally, the author also briefly explores commercial and strategic considerations as they relate to these legal issues.

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