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searching for Investigational New Drug 83 found (285 total)

alternate case: investigational New Drug

Cannabis policy of the George H. W. Bush administration (552 words) [view diff] exact match in snippet view article find links to article

In 1978, the Carter Administration founded the Compassionate Investigational New Drug program to provide federally-produced cannabis grown by the University

Cannabis policy of the Jimmy Carter administration (1,131 words) [view diff] exact match in snippet view article find links to article

cocaine, and seeing cannabis as a gateway drug. The Compassionate Investigational New Drug program (Compassionate IND) was founded in 1978 by the Carter administration

Pyridoxamine (1,517 words) [view diff] exact match in snippet view article find links to article

supplements on the grounds that pyridoxamine, as the subject of an Investigational New Drug Application with the FDA, is a drug and not a dietary supplement

Jacki Rickert (613 words) [view diff] exact match in snippet view article find links to article

1990 to begin getting marijuana from the federal Compassionate Investigational New Drug Program before President George Bush ended the program, in 1991

George McMahon (activist) (332 words) [view diff] exact match in snippet view article

last surviving patients enrolled in the federal Compassionate Investigational New Drug Program that began providing cannabis to patients in 1978. He lived

Elizabeth Eisenhauer (272 words) [view diff] exact match in snippet view article find links to article

of novel cancer therapies through her role as Director of the Investigational New Drug Program in the Canadian Cancer Trials Group. She received her Doctor

Cocaine esterase (856 words) [view diff] exact match in snippet view article find links to article

cocaine esterase 200 mg, i.v. solution) is being developed under an Investigational New Drug application (IND) for the treatment of cocaine intoxication. TNX-1300

Elvy Musikka (636 words) [view diff] exact match in snippet view article find links to article

three surviving patients qualified to enroll in the Compassionate Investigational New Drug Program, getting marijuana from the federal government. Born in

Keystone Nano (257 words) [view diff] case mismatch in snippet view article find links to article

of biological activity. In January 2017, the FDA approved the investigational new drug application, NanoLiposome, to assess the product as a form of treatment

Tonix Pharmaceuticals (5,272 words) [view diff] exact match in snippet view article find links to article

of an official written response from the FDA for a Type B pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA)

Brincidofovir (2,192 words) [view diff] case mismatch in snippet view article find links to article

October 2014, Chimerix received an FDA authorization for emergency investigational new drug applications of brincidofovir for the treatment of Ebola virus

Common Technical Document (394 words) [view diff] exact match in snippet view article find links to article

Research, Center for Drug Evaluation and (14 November 2023). "Investigational New Drug (IND) Application". FDA. Retrieved 15 January 2024. ICH Common

History of medical cannabis (3,038 words) [view diff] exact match in snippet view article find links to article

government. In May 2001, "The Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of Benefits and Adverse Effects of Legal

Robert C. Randall (356 words) [view diff] exact match in snippet view article find links to article

Medical Pot, ISBN 978-1560251668. Cannabis portal Compassionate Investigational New Drug program Zielinski, Graeme (8 June 2001). "Activist Robert C. Randall

COVID-19 vaccination in South Korea (1,133 words) [view diff] case mismatch in snippet view article find links to article

Novavax vaccines. On 9 November 2023, SK Bioscience submitted investigational new drug for GBP510 COVID-19 vaccine candidate to Korea Ministry of Food

Amatuximab (954 words) [view diff] exact match in snippet view article find links to article

the National Cancer Institute. Quickly following they opened an Investigational New Drug Application with the FDA in 2006 and initiated Phase I clinical

Artesunate (2,884 words) [view diff] case mismatch in snippet view article find links to article

uncomplicated malaria who are unable to take oral medications under an investigational new drug (IND) protocol. There has been no FDA-approved drug for treatment

ClinicalTrials.gov (1,865 words) [view diff] exact match in snippet view article find links to article

ClinicalTrials.gov, tracking drug efficacy studies resulting from approved Investigational New Drug (IND) applications (FDA Regulations 21 CFR Parts 312 and 812).

Cellular Dynamics International (1,617 words) [view diff] exact match in snippet view article find links to article

high throughput screens, and have been used as supporting data in Investigational New Drug (IND) submissions to the FDA. Reprogramming technology enables

ClinicalTrials.gov (1,865 words) [view diff] exact match in snippet view article find links to article

ClinicalTrials.gov, tracking drug efficacy studies resulting from approved Investigational New Drug (IND) applications (FDA Regulations 21 CFR Parts 312 and 812).

Human embryonic stem cells clinical trials (1,608 words) [view diff] exact match in snippet view article find links to article

newly developed pharmaceuticals. Researchers must complete an Investigational New Drug (IND) application in order to earn the FDA's approval. IND applications

List of Guidances for Statistics in Regulatory Affairs (3,027 words) [view diff] exact match in snippet view article find links to article

human subjects. FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications. This good review practice (GRP) document was prepared

Factor XIII deficiency (690 words) [view diff] exact match in snippet view article find links to article

concentrate is only available under the Federal Drug Administration's Investigational New Drug (IND) Program, or through clinical trial. Recombinant factor XIII

Burzynski Clinic (6,930 words) [view diff] exact match in snippet view article find links to article

treatment. The FDA wanted all of Burzynski's patients to be on an IND [Investigational New Drug (IND) Application], so that's what we did. All trials were paused

Brigatinib (796 words) [view diff] case mismatch in snippet view article find links to article

target for cancer therapy. Ariad Pharmaceuticals, Inc. filed an investigational new drug (IND) application to the US FDA on August 29, 2016. In 2016, brigatinib

Glossary of cannabis terms (9,489 words) [view diff] exact match in snippet view article find links to article

prohibition.] cola Topmost flower bud on a cannabis plant. Compassionate Investigational New Drug program After Robert Randall became the first person to successfully

Progressive vaccinia (1,052 words) [view diff] exact match in snippet view article find links to article

Vaccinia Immune Globulin Intravenous (Human) (VIGIV), Emergency Investigational New Drug (E-IND) both administered orally and topically, (in this case ST-246);

Ultragenyx (1,500 words) [view diff] exact match in snippet view article find links to article

Angelman Syndrome (KIK-AS)". 2020. "GeneTx and Ultragenyx Announce Investigational New Drug (IND)". CNN. January 15, 2020. Carpenter, T. O.; Whyte, M. P.;

Solithromycin (1,416 words) [view diff] case mismatch in snippet view article find links to article

patient safety trial as well as restricting the drug. In 2008, investigational new drug applications for solithromycin capsules and an intravenous formulation

JKB-122 (220 words) [view diff] exact match in snippet view article find links to article

S2CID 30160157. "Biostax Corp Announces the FDAs Acceptance of Three Investigational New Drug Applications (IND) Transfers for JKB-122 for the Treatment of NASH

Vedolizumab (2,341 words) [view diff] exact match in snippet view article find links to article

Published in the New England Journal of Medicine for Vedolizumab, an Investigational New Drug from Takeda for Moderately to Severely Active Ulcerative Colitis

Pherine (757 words) [view diff] case mismatch in snippet view article find links to article

Fasedienol (PH94B; Aloradine; 4,16-androstadien-3β-ol) is an investigational new drug proposed as an indication for the acute treatment of generalized

Investigator's brochure (606 words) [view diff] exact match in snippet view article find links to article

indications. Code of Federal Regulations, Title 21, Part 312, Investigational New Drug Application [2] Code of Federal Regulations, Title 21, Part 201

Fish oil (medical use) (598 words) [view diff] exact match in snippet view article

Retrieved 12 May 2020. Research, Center for Drug Evaluation and. "Investigational New Drug (IND) Application - How to request Omegaven for Expanded Access

Rabeprazole (6,229 words) [view diff] case mismatch in snippet view article find links to article

and LY307640, the pre-investigational new drug application was submitted on October 28, 1998. The final investigational new drug application was submitted

Hydrocodone/ibuprofen (1,662 words) [view diff] case mismatch in snippet view article find links to article

approval from the FDA as if it were a new drug. Knoll filed an investigational new drug application on 30 December 1986. A new drug application was later

Cure Rare Disease (730 words) [view diff] exact match in snippet view article find links to article

and safety testing, Cure Rare Disease secured approval of the Investigational New Drug (IND) application from the United States Food and Drug Administration

Windtree Therapeutics (336 words) [view diff] case mismatch in snippet view article find links to article

since U.S. Food and Drug Administration (FDA) had cleared the investigational new drug (IND) application. The phase II consists of two steps to evaluate

JNJ-55308942 (220 words) [view diff] exact match in snippet view article find links to article

JNJ-55308942 Legal status Legal status Investigational New Drug Identifiers IUPAC name (S)-(3-fluoro-2-(trifluoromethyl)pyridin-4-yl)(1-(5-fluoropyrim

Urachal cancer (1,647 words) [view diff] exact match in snippet view article find links to article

given daily in patients with solid tumors: IND.122, a study of the Investigational New Drug Program of the National Cancer Institute of Canada Clinical Trials

Urachal cancer (1,647 words) [view diff] exact match in snippet view article find links to article

given daily in patients with solid tumors: IND.122, a study of the Investigational New Drug Program of the National Cancer Institute of Canada Clinical Trials

Psilocybin therapy (1,862 words) [view diff] exact match in snippet view article find links to article

Schedule I controlled substances, activities associated with IND (Investigational New Drug) must comply with the applicable Drug Enforcement Administration

Multidisciplinary Association for Psychedelic Studies (2,538 words) [view diff] exact match in snippet view article find links to article

for medical and research purposes, including the Compassionate Investigational New Drug program. United States federal law registers cannabis as a Schedule

Edwin Rubel (1,279 words) [view diff] exact match in snippet view article find links to article

"Oricula Therapeutics Gets FDA Clearance for Clinical Trials with Investigational New Drug". Hearing News Watch. 2018-02-07. Retrieved 2021-10-27. "Edwin

Clinical trial (12,658 words) [view diff] exact match in snippet view article find links to article

2019. Retrieved 11 November 2017. "Investigational New Drug (IND) Application - Final Rule: Investigational New Drug Safety Reporting Requirements for

David A. Sinclair (2,536 words) [view diff] case mismatch in snippet view article find links to article

because Metro Biotech had registered NMN and publicized NMN as an investigational new drug. In 2023, Sinclair co-founded Tally Health, a longevity company

Kevin Pauza (1,139 words) [view diff] exact match in snippet view article find links to article

On July 18, 2013, it was announced the results of its Phase III Investigational New Drug study had not met its success criteria, and injections of the Fibrin

Clinical pharmaceutical scientist (2,024 words) [view diff] case mismatch in snippet view article find links to article

serve as principal investigators (PI's) on clinical trials for investigational new drug applications in the United States, provided that they meet the

Center for Innovative Phage Applications and Therapeutics (933 words) [view diff] exact match in snippet view article find links to article

been administered intravenously (IV), by utilizing the Emergency Investigational New Drug (eIND) process which is regulated by the FDA. Tom Patterson was

Tacrolimus (4,357 words) [view diff] case mismatch in snippet view article find links to article

"Tsukuba macrolide immunosuppressant". The early development (investigational new drug phase) of tacrolimus, called at the time by the development code

Symphogen (1,527 words) [view diff] exact match in snippet view article find links to article

pre-clinical development of Sym002, which allows submission of an Investigational New Drug application for new safety studies. Recombinant monoclonal antibody

National Institute on Drug Abuse (4,577 words) [view diff] exact match in snippet view article find links to article

for medical and research purposes, including the Compassionate Investigational New Drug program. A Fast Company article pointed out, "Based on the photographic

JNJ-54175446 (439 words) [view diff] exact match in snippet view article find links to article

JNJ-54175446 Legal status Legal status Investigational New Drug Identifiers IUPAC name (R)-(2-chloro-3-(trifluoromethyl)phenyl)(1-(5-fluoropyrimidin-2-yl)-4-methyl-6

Ebola virus disease treatment research (3,518 words) [view diff] case mismatch in snippet view article find links to article

antiviral drug, has been granted an emergency FDA approval as an investigational new drug for the treatment of Ebola after it was found to be effective against

Scioderm (849 words) [view diff] exact match in snippet view article find links to article

original on 6 September 2015. Retrieved 28 August 2015. "Scioderm's Investigational New Drug (IND) Application for SD-101 for Treatment of Epidermolysis Bullosa

Seagen (3,140 words) [view diff] case mismatch in snippet view article find links to article

achievement in collaboration with Bayer for the submission of investigational new drug application with the FDA 5 October: discontinuation of Phase IIb

Gamma-Hydroxybutyric acid (8,754 words) [view diff] case mismatch in snippet view article find links to article

had formalized, as a company called Orphan Medical had filed an investigational new drug application and was running clinical trials with the intention

Russell Dahl (1,224 words) [view diff] exact match in snippet view article find links to article

Business. Retrieved 2023-08-22. "Neurodon Announces Initiation of Investigational New Drug (IND)-Enabling Studies for NDC-0009, a Novel Small Molecule for

NcRNA therapy (5,353 words) [view diff] exact match in snippet view article find links to article

Research, Center for Drug Evaluation and (7 December 2021). "Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide

Buprenorphine (7,271 words) [view diff] case mismatch in snippet view article find links to article

infants enrolled in a clinical trial conducted under an FDA-approved investigational new drug (IND) application. Preliminary research suggests that buprenorphine

Immunoglobulin therapy (5,507 words) [view diff] exact match in snippet view article find links to article

from the original on 7 June 2013. "FDA Approves Octapharma USA Investigational New Drug Application for Severe COVID-19 Patients". www.businesswire.com

Brownie Mary (4,490 words) [view diff] exact match in snippet view article find links to article

purposes, Mason had terminated the federal government's Compassionate Investigational New Drug program (Compassionate IND) in March 1992. The Carter administration

Cost of drug development (1,690 words) [view diff] exact match in snippet view article find links to article

chemical compound, pharmaceutical companies move forward with the Investigational New Drug (IND) Application from the FDA. After the investigation into the

Richard Pestell (2,739 words) [view diff] case mismatch in snippet view article find links to article

research served as the preclinical reference citation in the IND (investigational new drug) application to the FDA for the initial clinical research programs

Food and Drug Administration (11,587 words) [view diff] exact match in snippet view article find links to article

on the Critical Path to New Medical Products. The Compassionate Investigational New Drug program was created after Randall v. U.S. ruled in favor of Robert

Christopher Largen (2,177 words) [view diff] exact match in snippet view article find links to article

medical Cannabis from the United States Government's Compassionate Investigational New Drug program. McMahon used the government Cannabis to treat pain, spasms

Fluoxetine (11,667 words) [view diff] exact match in snippet view article find links to article

Products Company, a division of Eli Lilly & Company, filed an Investigational New Drug application to the U.S. Food and Drug Administration (FDA) for

Discovery and development of proton pump inhibitors (4,718 words) [view diff] exact match in snippet view article find links to article

gave the compound much more stability at neutral pH. In 1980, an Investigational New Drug (IND) application was filed and omeprazole was taken into Phase

Declaration of Helsinki (7,266 words) [view diff] case mismatch in snippet view article find links to article

Subject Protection: Foreign clinical studies not conducted under an investigational new drug application. Final Rule April 28 2008, effective October 27 2008"

Criticism of the Food and Drug Administration (5,595 words) [view diff] case mismatch in snippet view article find links to article

Kefauver Harris Amendment, the average time from the filing of an investigational new drug application (IND) to approval was 7 months. By 1998, it took an

Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (3,818 words) [view diff] case mismatch in snippet view article find links to article

studies are not ethical or practicable, and that has an approved investigational new drug application or investigational device exemption, may request and

University of Mississippi (12,053 words) [view diff] exact match in snippet view article find links to article

medical marijuana patients grandfathered into the Compassionate Investigational New Drug program. The facility is the only source of marijuana medical researchers

C-Met inhibitor (3,549 words) [view diff] exact match in snippet view article find links to article

medullary thyroid carcinoma; GBM: glioblastoma; RCC: renal cell carcinoma; HNSCC: head and neck squamous cell cainoma; IND: Investigational New Drug.

Legal history of cannabis in the United States (11,769 words) [view diff] exact match in snippet view article find links to article

restored, setting in motion the creation of the Compassionate Investigational New Drug program shortly thereafter. The program allowed patients with serious

Gene therapy (17,769 words) [view diff] case mismatch in snippet view article find links to article

DNA Advisory Committee. Researchers seeking federal funds for an investigational new drug application, (commonly the case for somatic human genetic engineering

Phage therapy (11,000 words) [view diff] exact match in snippet view article find links to article

interventions have been performed in the US under the FDA's emergency Investigational New Drug (eIND) protocol. Some patients have been treated with phages under

Anil Potti (4,834 words) [view diff] exact match in snippet view article find links to article

its initiation, and concluded that the study would require an Investigational New Drug application, which had not been submitted. An FDA audit in 2011

4-Ipomeanol (3,270 words) [view diff] case mismatch in snippet view article find links to article

Grieshaber CK, Chabner BA, Boyd MR. 1989. 4-IPOMEANOL - A NOVEL INVESTIGATIONAL NEW DRUG FOR LUNG-CANCER. Journal of the National Cancer Institute 81(15):1133-1143

Ebola virus cases in the United States (11,904 words) [view diff] exact match in snippet view article find links to article

2014. Retrieved October 7, 2014. "Chimerix Announces Emergency Investigational New Drug Applications for Brincidofovir Authorized by FDA for Patients With

Gender disparities in health (11,437 words) [view diff] exact match in snippet view article find links to article

Effectiveness Data for Certain Subgroups of the Population in Investigational New Drug Application Reports and New Drug Applications" regulations mandated

Multiple sclerosis drug pipeline (9,409 words) [view diff] case mismatch in snippet view article find links to article

years per patient. In July 2021, the FDA gave the go-ahead for an investigational new drug application (IND) for the phase 3 ENSURE program, which will evaluate

List of MeSH codes (E05) (5,386 words) [view diff] case mismatch in snippet view article

MeSH E05.337.250.500 – multicenter studies MeSH E05.337.300.400 – investigational new drug application MeSH E05.337.550.200 – drug screening assays, antitumor

Novartis v. Union of India & Others (5,296 words) [view diff] exact match in snippet view article find links to article

on 2 August 2018. Retrieved 2 August 2018. US Patent 6,894,051 Investigational New Drug Application (IND # 55,666) for Gleevec was filed on 9 April 1998