Intraocular lenses for children in the year 2000: When is oversight by the institutional review board or food and drug administration required?

2000 ◽  
Vol 4 (6) ◽  
pp. 325 ◽  
Author(s):  
M.Edward Wilson
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Intraocular Lenses ◽  
Institutional Review Board ◽  
Institutional Review ◽  
Year 2000

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 Materials and methods: The data have been archived from the official website of United States food and drug administration comprising all the applications approved by this regulatory agency from the year 2000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

scholarly journals Bilateral implantation of +3.0 D multifocal toric intraocular lenses: results of a US Food and Drug Administration clinical trial

2017 ◽  
Vol Volume 11 ◽  
pp. 1321-1331 ◽  
Author(s):  
Robert Lehmann ◽  
Satish Modi ◽  
Bret Fisher ◽  
Magda Michna ◽  
Michael Snyder
Keyword(s):  
Clinical Trial ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Intraocular Lenses

Project Zero Delay: A Process for Accelerating the Activation of Cancer Clinical Trials

2009 ◽  
Vol 27 (26) ◽  
pp. 4433-4440 ◽  
Author(s):  
Razelle Kurzrock ◽  
Susan Pilat ◽  
Marcel Bartolazzi ◽  
Dwana Sanders ◽  
Jill Van Wart Hood ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Drug Administration ◽  
Strategic Alliance ◽  
Food And Drug Administration ◽  
Good Practice ◽  
New Drugs ◽  
Cancer Center ◽  
Institutional Review ◽  
Regulatory Submissions

Drug development in cancer research is lengthy and expensive. One of the rate-limiting steps is the initiation of first-in-human (phase I) trials. Three to 6 months can elapse between investigational new drug (IND) approval by the US Food and Drug Administration and the entry of a first patient. Issues related to patient participation have been well analyzed, but the administrative processes relevant to implementing clinical trials have received less attention. While industry and academia often partner for the performance of phase I studies, their administrative processes are generally performed independently, and their timelines driven by different priorities: safety reviews, clinical operations, regulatory submissions, and contracting of clinical delivery vendors for industry; contracts, budgets, and institutional review board approval for academia. Both processes converge on US Food and Drug Administration approval of an IND. In the context of a strategic alliance between M. D. Anderson Cancer Center and AstraZeneca Pharmaceuticals LP, a concerted effort has been made to eliminate delays in implementing clinical trials. These efforts focused on close communications, identifying and matching key timelines, alignment of priorities, and tackling administrative processes in parallel, rather than sequentially. In a recent, first-in-human trial, the study was activated and the first patient identified in 46 days from completion of the final study protocol and about 48 hours after final US Food and Drug Administration IND approval, reducing the overall timeline by about 3 months, while meeting all clinical good practice guidelines. Eliminating administrative delays can accelerate the evaluation of new drugs without compromising patient safety or the quality of clinical research.

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