*Drug development

... as an Investigational New Drug application or IND. If the IND is approved, development moves to the clinical phase. Clinical ... In the United States, this process is called a "new drug application" or NDA. Most NCEs fail during drug development, either ... Council for International Organizations of Medical Sciences Drug design Drug repositioning Generic drug International ... and may include the step of obtaining regulatory approval with a new drug application to market the drug. Broadly, the process ...

*Investigational New Drug

... regulates the application of IND drugs to US service personnel. "Investigational New Drug (IND) Application". FDA. Retrieved 7 ... Investigational New Drug (IND) Application Process Center for Drug Evaluation and Research, Food and Drug Administration. ICH ... The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical ... before a marketing application for the drug has been approved. The FDA reviews the IND application for safety to assure that ...

*Abaloparatide

"Radius Health Has Submitted a Marketing Authorization Application for the Investigational Drug Abaloparatide-SC for the ... "Radius Announces FDA Acceptance for Filing of New Drug Application for Abaloparatide-SC for the Treatment of Postmenopausal ... "Drugs@FDA: FDA Approved Drug Products". www.accessdata.fda.gov. Retrieved 2017-11-03. Jolette, Jacquelin; Attalla, Bassem; ... The patents relate to the drug composition (US 8148333), and the drug delivery methods (US 7803770 B2 and US 8748382-B2). As ...

*Human embryonic stem cells clinical trials

Researchers must complete an Investigational New Drug (IND) application in order to earn the FDA's approval. IND applications ... 2011). "Investigational New Drug (IND) Application." Retrieved April 12, 2012, from http://www.fda.gov/drugs/ ... Testing for new drugs must successfully go through three phases of research before a drug can be marketed to the public. In ... drug manufacturing information explaining how and where the drug will be produced, and a detailed research protocol stating who ...

*N6-Cyclopentyladenosine

Expert Opinion on Investigational Drugs. 17 (12): 1901-1910. doi:10.1517/13543780802497284. PMID 19012505. Franchetti P, ... Elzein E, Zablocki J (December 2008). "A1 adenosine receptor agonists and their potential therapeutic applications". ... N6-Cyclopentyladenosine (CPA) is a drug which acts as a selective adenosine A1 receptor agonist. It has mainly cardiovascular ...

*Keystone Nano

In January 2017, the FDA approved the investigational new drug application, NanoLiposome, to assess the product as a form of ... "FDA Approves Investigational New Drug Application for Ceramide NanoLiposome". Pharmacy Times. Retrieved 14 January 2017. " ... "Investigational cancer compound receives FDA approval to begin human trials". Penn State News. ...

*Viralytics

"Allowance of FDA Investigational New Drug (IND) Application for Cavatak Phase II Melanoma Trial" (PDF). asx.com.au. 27 June ... "Investigational New Drug Application Lodged With the FDA" (PDF). asx.com.au. 3 November 2010. Retrieved 4 December 2015. " ... This trial took place under an Investigational New Drug application. The trial completed in 2015 with favourable results and ... The drug was granted Orphan Drug status in advanced melanoma in December 2005. Around 1999 a team led by the virologist ...

*List of Guidances for Statistics in Regulatory Affairs

FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications. This good review practice (GRP) document ... The randomization is discussed in: FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications, chapter ... Clinical Review of Investigational New Drug Applications CHMP/EWP/5872/03 Data monitoring committees FDA - Establishment and ... from the pre-IND phase to the time of the pre-new drug application/biologics license application meeting. CHMP/EWP/5872/03: ...

*Clinical research

are submitted in support of an Investigational New Drug (IND) application to the FDA for review prior to conducting studies ... FDA Page last updated 27 October 2014 Investigational New Drug (IND) Application Mohamadi, Amin; Asghari, Fariba; Rashidian, ... The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes ... 70% of drugs advance to the next phase. Before pharmaceutical companies start clinical trials on a drug, they conduct extensive ...

*Deathstalker

... and are only available as investigational drugs (INDs). The US Armed Forces maintain an investigational drug application for ... there is the additional complicating factor that none of the existing antivenoms are approved by the Food and Drug ... and the Florida Antivenin Bank maintains an IND application for Sanofi Pasteur's Scorpifav antivenom. A component of the ...

*Clinafloxacin

The investigational new drug application was withdrawn by the manufacturer in 1999, citing safety concerns. Clinafloxacin is ... drug-induced light sensitivity, and multiple drug-drug interactions. Clinical trials have been done to assess its efficacy in ... About half of an administered clinafloxacin dose is found unchanged in the urine, meaning that the drug is cleared from the ... Clinafloxacin is an investigational fluoroquinolone antibiotic. Despite its promising antibiotic activity, the clinical ...

*Rabeprazole

... the pre-investigational new drug application was submitted on October 28, 1998. The final investigational new drug application ... Drugs.com. Retrieved 5 October 2017. "Application Number 20-973/S-009" (PDF). Center for Drug Evaluation and Research. ... Center for Drug Evaluation and Research. Retrieved 3 December 2017. "Drugs@FDA". accessdata.fda.gov. US FDA. Retrieved 9 ... Clinically serious drug-drug interactions may involve the acid-suppression effects of rabeprazole. For example, rabeprazole ...

*Biocon

An investigational new drug application (IND) with the US Food and Drug Administration was filed in December. T1h is a novel ... an Oral Insulin drug. 2014 - Biocon received Marketing Authorization from the Drugs Controller General of India (DCGI) for its ... The drug has been jointly developed by Biocon and US-based generic pharmaceutical major Mylan and will be manufactured in ... The generic version of the drug named Harvoni will be sold under the brand name CIMIVIR-L. 2016 - The first Indian company to ...

*Brigatinib

filed an investigational new drug (IND) application to the US FDA on August 29, 2016. In 2016, brigatinib was granted orphan ... "ARIAD Announces Presentation on Its Investigational Lung Cancer Drug Candidate, AP26113, a Dual Inhibitor of ALK and EGFR, at ... Brigatinib received Breakthrough Therapy designation from the U.S. Food and Drug Administration in 2014. In March 2016, The ... Brigatinib (INN,, marketed as Alunbrig) is an investigational small-molecule targeted cancer therapy being developed by ARIAD ...

*Ebola virus cases in the United States

"Chimerix Announces Emergency Investigational New Drug Applications for Brincidofovir Authorized by FDA for Patients With Ebola ... They both recovered, but there was no confirmation or proof that the drug was a factor. A Spanish priest with Ebola had taken ... "Pre-application Webinar Agenda "Opportunities for Collaborative Research at the NIH Clinical Center" X02 (PAR-13-357) and U01 ( ... "Ebola drug likely saved American patients". CNN.com. August 8, 2014. Retrieved August 8, 2014. Steenhuysen, Julie. "Ebola ...

*John Zhang (scientist)

... and requires an Investigational New Drug application. In contrast, the UK became the first country to legalize it, in 2015. ...

*Domperidone

... for use in people with treatment-refractory gastrointestinal symptoms under an FDA Investigational New Drug application. ... "FDA warns against women using unapproved drug, domperidone to increase milk production." U.S. Food and Drug Administration 7 ... 147-. ISBN 978-0-7817-1750-2. Youssef AS, Parkman HP, Nagar S (2015). "Drug-drug interactions in pharmacologic management of ... thus increasing the concentration of domperidone and potential side effects of the drug. This is of concern as both drugs may ...

*Declaration of Helsinki

Foreign clinical studies not conducted under an investigational new drug application. Final Rule April 28 2008, effective ... criticised by Levine was removed to emphasise the more general application of ethical principles, but the application of the ... Center for Drug Evaluation and Research. Guidance for industry: acceptance of foreign clinical studies. March, 2001 Temple R. ... The Nation May 19, 2008 "Trials on trial: The Food and Drug Administration should rethink its rejection of the Declaration of ...

*4-Chlorokynurenine

VistaGen filed an Investigational New Drug application with the FDA for use of AV-101 in neuropathic pain in 2013. As of 2013, ... List of investigational antidepressants Laube B, Hirai H, Sturgess M, Betz H, Kuhse J (1997). "Molecular determinants of ... Drug Discovery. 12 (1): 64-82. doi:10.1038/nrd3793. PMID 23237916. "School of Medicine Professor Wins University System of ... Enters Late-Stage Preclinical Development Program for Lead Epilepsy Drug Candidate -". PR Newswire. November 19, 2003. " ...

*Scioderm

"Scioderm's Investigational New Drug (IND) Application for SD-101 for Treatment of Epidermolysis Bullosa (EB) Allowed by the FDA ... Zorblisa is the first drug to ever enter Phase 3 development for the treatment of EB. Stem cell research for Epidermolysis ... Hein, Alexandria (28 July 2015). "Family of NYC girl with skin-blistering condition sees hope in new drug". FoxNews.com. Lupkin ... In April 2013 Scioderm received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for its ...

*Discovery and development of proton pump inhibitors

In 1980, an Investigational New Drug (IND) application was filed and omeprazole was taken into Phase III human trials in 1982. ... Silverman, Richard B. (2004). "Receptors". The organic chemistry of drug design and drug action (2nd ed.). Academic Press. p. ... PPIs also can bind to other types of proton pumps such as those that occur in cancer cells and are finding applications in the ... These drugs have emerged as the treatment of choice for acid-related diseases, including gastroesophageal reflux disease (GERD ...

*Buprenorphine

Use currently is limited to infants enrolled in a clinical trial conducted under an FDA approved investigational new drug (IND ... Possible therapeutic applications as animal models show antidepressive, anxiolytic, stress relieving, and anti-addictive ... 1998). Problems of Drug Dependence, 1998: Proceedings of the 66th Annual Scientific Meeting, The College on Problems of Drug ... The FDA rescheduled buprenorphine from a Schedule V drug to a Schedule III drug just before approval of Subutex and Suboxone. ...

*Named patient programs

Within the United States, pre-approval demand is generally met through treatment IND (investigational new drug) applications ( ... Expanded access Investigational New Drug Helene S (2010). "EU Compassionate Use Programmes (CUPs): Regulatory Framework and ... If the program is in place too early, the company might not have an adequate supply of drug available to meet the named patient ... Through these programs, patients are able to access drugs in late-stage clinical trials or approved in other countries for a ...

*RNA silencing

In 2004, the first Investigational New Drug applications for siRNA were filed in the United States with the Food and Drug ... As with conventional manufactured drugs, the main challenge in developing successful offshoots of the RNAi-based drugs is the ... The future successful drugs will be the ones who are able to land where needed, probably with the help of nanobots. Below is a ... Karagiannis TC, El-Osta A (Oct 2005). "RNA interference and potential therapeutic applications of short interfering RNAs". ...

*Brincidofovir

"Chimerix Announces Emergency Investigational New Drug Applications for Brincidofovir Authorized by FDA for Patients With Ebola ... On October 6, 2014, Chimerix received an FDA authorization for emergency investigational new drug applications of brincidofovir ... The new use of the drug had the potential to interfere with the process to get the drug approved and widely marketed.[citation ... Chimerix to Conduct Ebola Drug Trial: Drug Company Gets FDA Approval to Start Trial Immediately in Infected Patients "Trials of ...

*CX717

In 2005 the U.S. Food and Drug Administration (FDA) accepted Cortex Pharmaceuticals' Investigational New Drug (IND) application ... These drugs were reasonably effective at reducing the symptoms of Alzheimer's and it was hoped that they could also slow the ... Other AMPAkine drugs from Cortex Pharmaceuticals such as CX-546 and CX-614 have already been researched for use in treating ... CX-717 and CX-1739 are newer and more potent drugs in the same series. The chemical structures of CX-717 and CX-1739 have not ...

*Expanded access

Individuals and their physicians can apply for use of an investigational drug using FDA Form 3926, an application form created ... Drugs for Treatment Use and Charging for Investigational Drugs Final FDA Rules on Expanded Access to Investigational Drugs for ... January 2017 Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs ... The drug manufacturing company must agree to provide the investigational drug for expanded access use. FDA cannot compel a ...