An IND, or investigational new drug application, is a submission to the U.S. Food and Drug Administration (FDA) requesting permission to initiate a clinical study of a new drug product in the United States. From a legal perspective, the IND is a request for exemption from the act's ...
The manufacturing process is suitable to preserve the strength and dosage of the drug Once submitted, the FDA takes 60 days to decide if it will be filed for further review. The difference between IND and NDA As you can see in the figure shown above, the drug development timeline is a ...
and you can quickly understand how demand is outpacing supply. The FDA receives roughly190 IND submissions each quarter. In the fiscal year 2021, the most recent year reported by the agency, they received 777
Immunotherapies play a big role in the Biden Administrations’Cancer Moonshot program, the goal of which is to “reduce cancer death rates by 50% over the next 25 years and improve the experience of living with and surviving cancer.”As part of this program, congress has invested $1.8B to ...
It is a long, complex and expensive process, and many sponsors are not equipped, resourced or prepared to perform all trial-related duties and functions themselves. For this reason, sponsors may choose to outsource all or part of the trial-related tasks to a company called a contract research...
It is widely accepted that intellectual property legal requirements such as patents and data exclusivity can affect access to medicines, but to date there has not been a comprehensive review of the empirical evidence on this topic. The World Trade Organization’s Agreement on Trade-Related Aspects ...
ADVM-022. The candidate is being developed for treating wet age-related macular degeneration ("AMD"). Adverum is in the process of filing a pre-investigational new drug (IND), following its meeting with the FDA in the first quarter of 2017. The company is also developing another anti-VEGF...
End-of-phase 2A (EOP2A) meetings are formalPDUFA Type C meetingsheld between IND sponsors and CDER or CBER. EOP2A meetings provide an opportunity for in-depth, exploratory discussion with the FDA focused on optimizing next steps in drug development. The overall purpose of these meetings is to...
It remains to be seen how industry responds to FDA's newly reissued final guidance advising firms to file Investigational New Drug applications for studies exploring would-be cosmetics' structure/function benefits, and how rigorously the agency enforces its position. Attorney Paul Hyman speculates tha...
GLP regulations were first introduced by the FDA in 1978 and have become an integral part of nonclinical drug development. A key component of GLP is an independent quality assurance unit intended to monitor study conduct, analysis, and reporting of nonclinical studies. Allucent’s nonclinical TK...