Results 271 to 280 of about 135,991 (315)

US Prescription Drug User Fee Act (PDUFA): An Introduction for the Pharmaceutical Physician

Pharmaceutical Medicine, 2016
Originally enacted to address the delays in US Food and Drug Administration (FDA) new drug review due to chronic understaffing and outdated systems, the Prescription Drug User Fee Act (PDUFA) of 1992, with its 5-year reauthorization cycle, enabled rapid rigorous review and ushered in a new era of continuing program innovation, evaluation, and ...
Theresa M. Mullin, Joshua L. Barton
openaire   +1 more source

Improving Time to Pharmaceutical Approval: An Analysis of the Prescription Drug User Fee Act Process

Drug Information Journal, 2012
The Prescription Drug User Fee Act of 1992 (PDUFA) established pharmaceutical review performance goals and authorized the US Food and Drug Administration (FDA) to collect user fees in conjunction with pharmaceutical marketing applications. There have been 3 subsequent reauthorizations of PDUFA; the most recent, referred to as PDUFA IV, was enacted with
Andrea C. Masciale, Patricia L. DeSantis, Jay P. Siegel   +2 more
openaire   +1 more source

Pharmaceutical Spending in Fee-for-Service Medicare

JAMA, 2022
Walid F, Gellad, Inmaculada, Hernandez
openaire   +2 more sources

Corporate Governance and Audit Fees of Listed Pharmaceutical Firms in Nigeria

2019
This study aimed at ascertaining those corporate governance variables that determine the audit fees of listed pharmaceutical firms in Nigeria for a 6-year period from 2012 to 2017. The study adopts ex-post facto and Panel research design and secondary data are obtained from the annual audited accounts of the sample of seven (7) out of the population of
openaire   +1 more source

Audit Client Characteristics and Audit Fees of Listed Pharmaceutical Firms in Nigeria

2019
This study aimed at investigating the relationship between audit client characteristics and audit fees of listed pharmaceutical firms in Nigeria for a 6-year period from 2012 to 2017. The study adopted a historical research design and secondary data were obtained from the sample size of seven out of the population of eleven listed pharmaceutical firms ...
openaire   +1 more source

Relationship Between Pharmaceutical Company User Fees and Drug Approvals in Canada and Australia: A Hypothesis-Generating Study

Annals of Pharmacotherapy, 2006
Background: Since the early- to mid-1990s, drug companies have paid fees for a variety of activities carried out by the Therapeutic Products Directorate in Canada and the Therapeutic Goods Administration in Australia. Objective: To explore whether changes in approval times for new active substances and in the percentage of new drug submissions ...
openaire   +2 more sources

Charging for hospital pharmaceutical services: Flat fee based on the medication record

American Journal of Health-System Pharmacy, 1979
A 200-bed hospital's change in pricing drug products from a cost-plus-fee system to a flat fee per dose based on the medication administration record (MAR) is described. With the flat-fee system, drug charges are not recorded when the drug is dispensed by the pharmacy; data for charging doses are obtained directly from the MAR forms generated by the ...
openaire   +2 more sources

Royal Pharmaceutical Society membership fees 2024

Pharmaceutical Journal, 2023
openaire   +1 more source

Pharmaceutical treatment of osteoarthritis

Osteoarthritis and Cartilage, 2023
Michael J Richard, Jeffrey Driban, Timothy E Mcalindon   +2 more
exaly  

Pharmaceutical cocrystals: A review of preparations, physicochemical properties and applications

Acta Pharmaceutica Sinica B, 2021
Ting Cai
exaly