FDA grants EBTATE investigational new drug status
Biotechnology developer Molecular Targeting Technologies has received investigationa...Read more on AuntMinnie.comRelated Reading: Molecular Targeting licenses agent from MCW Molecular Targeting licenses dyes from MGH Molecular Targeting, Bexion join forces (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - March 4, 2021 Category: Radiology Source Type: news

Division of Oncology 2 (DO2)
The Division of Oncology 2 (DO2) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for the following therapeutic areas: gastrointestinal, lung, and head and neck cancers; neuro-oncology, rare cancers, pediatric (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 28, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine
FDA releases a new draft guidance on investigational new drug (IND) submissions for individualized ASO drug products. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 4, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Pittsburgh-based LyGenesis receives FDA clearance for new drug application
Pittsburgh-based LyGenesis Inc. received U.S. Food and Drug Administration clearance for its Investigational New Drug application, according to a news release. LyGenesis was founded to develop cell therapies to enable organ regeneration. With this new application, LyGenesis will move forward with a Phase 2a study on the safety, tolerance and efficacy of its novel cell therapy for end stage liver disease, according to the release.  LyGenesis also recent ly finalized $11 million in private financing… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - December 31, 2020 Category: American Health Authors: Julia Mericle Source Type: news

BAT progresses COVID-19 candidate vaccine into Phase I human clinical trials
(R&D at British American Tobacco) BAT's US Bio-tech arm, Kentucky BioProcessing (KBP) today announced plans to commence a Phase I first-time-in-human study of its COVID-19 vaccine candidate following approval of its Investigational New Drug application by the US Food and Drug Administration (FDA). Enrolment for the study is expected to begin shortly. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 16, 2020 Category: International Medicine & Public Health Source Type: news

Rhizen Pharmaceuticals gets USFDA approval for phase one clinical trials for Covid-19 drug
The Switzerland-based firm, which is a clinical-stage oncology-focussed biopharmaceutical company, has received approval for its investigational new drug (IND) application from the US Food and Drug Administration (FDA) to study its oral Dihydroorotate dehydrogenase (DHOHD) inhibitor for SARS-CoV-2 infection, Rhizen Pharmaceuticals S A said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 2, 2020 Category: Pharmaceuticals Source Type: news

COVID-19 vaccine candidate tested preclinically at UAB nears first clinical test in people
(University of Alabama at Birmingham) A COVID-19 vaccine candidate that underwent extensive preclinical testing at the University of Alabama at Birmingham this spring and summer is poised for clinical testing to begin in December. Maryland-based Altimmune Inc., a clinical stage biopharmaceutical company, has submitted an Investigational New Drug, or IND, application to the United States Food and Drug Administration to commence a Phase 1 clinical study of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - November 25, 2020 Category: Infectious Diseases Source Type: news

Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND
This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether research studies involving human subjects must be conducted under an investigational new drug application (IND). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Zydus Cadila files investigational new drug application for COVID-19 treatment
Drug firm Zydus Cadila on Tuesday said it has filed the investigational new drug (IND) application for ZYIL1, positioned for management of critically ill COVID-19 patients. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 3, 2020 Category: Pharmaceuticals Source Type: news

Arca Biopharma files application for Covid-19 drug treatment
Westminster-based biotech company Arca Biopharma has submitted an Investigational New Drug application for Covid-19. The application was filed under the Coronavirus Treatment Acceleration Program. The application will evaluate the use of one of Arca Biopharma's drugs, AB201, as a treatment for patients hospitalized with Covid-19. The 13-employee Arca Biopharma typically focuses on genetically targeted therapie s for cardiovascular diseases. AB201 is believed to be effective with RNA viruses, which… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 22, 2020 Category: Pharmaceuticals Authors: Jensen Werley Source Type: news

Westminster-based Arca Biopharma is developing a treatment for Covid-19
Arca Biopharma is in the process of developing a Covid-19 treatment. The Westminster-based biotech company, which focuses on genetically targeted therapies for cardiovascular diseases, plans to submit its Investigational New Drug application with the U.S. Food and Drug Administration in September. The application is for AB201, a drug that has the potential to work as a treatment for severe Covid-19 patients, said Derek Cole, head of investor relations for the company. AB201 is a drug that Arca… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 28, 2020 Category: Pharmaceuticals Authors: Jensen Werley Source Type: news

Westminster-based Arca Biopharma is developing a treatment for Covid-19
Arca Biopharma is in the process of developing a Covid-19 treatment. The Westminster-based biotech company, which focuses on genetically targeted therapies for cardiovascular diseases, plans to submit its Investigational New Drug application with the U.S. Food and Drug Administration in September. The application is for AB201, a drug that has the potential to work as a treatment for severe Covid-19 patients, said Derek Cole, head of investor relations for the company. AB201 is a drug that Arca… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 28, 2020 Category: Biotechnology Authors: Jensen Werley Source Type: news

Ensuring the Safety of Patients in Clinical Trials Studying Investigational New Drugs to Prevent or Treat COVID-19
FDA has a critical role in ensuring the safety of patients in clinical trials studying drugs for the prevention or treatment of COVID-19 that require an investigational new drug (IND) application. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 14, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Merck initiates first clinical trial of TLR7 and 8 inhibitor as a potential treatment for severe symptoms of COVID-19 infection
Merck, a leading science and technology company, announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug application (IND) for M5049 for the treatment of patients with Covid-19 pneumonia. Merck will initiate a Phase II randomized, controlled clinical study evaluating the safety and efficacy of M5049 in this patient population. (Source: World Pharma News)
Source: World Pharma News - July 3, 2020 Category: Pharmaceuticals Tags: Featured Merck Group Business and Industry Source Type: news

Citius Receives FDA Response on Pre-Investigational New Drug (PIND) Application for its Induced Mesenchymal Stem Cells (iMSCs) to Treat Acute Respiratory Distress Syndrome (ARDS) in Patients with COVID-19
FDA provides very specific guidelines to study iPSC-derived MSCs Company intends to submit an IND application for its iMSC therapy for patients with ARDS associated with COVID-19 CRANFORD, N.J., June 26, 2020 -- (Healthcare Sales & Marketing Network)... Biopharmaceuticals, FDA Citius Pharmaceuticals, Induced Mesenchymal Stem Cells, ARDS (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 26, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Octapharma USA IND application for severe COVID-19 patients
(Yankee Public Relations) The US Food and Drug Administration (FDA) has approved the investigational new drug (IND) application submitted by Octapharma USA for a phase three clinical trial on the efficacy and safety of Octagam 10% [Immune Globulin Intravenous (Human)] therapy in COVID-19 patients with severe disease progression. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - May 20, 2020 Category: Infectious Diseases Source Type: news

CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 6, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Alpha Cognition, Inc. Receives FDA/PMDA Regulatory Guidance for Alpha-1062 Alzheimer's Therapy
VANCOUVER, British Columbia, April 30, 2020 -- (Healthcare Sales & Marketing Network) -- Alpha Cognition Inc. (ACI) today announced that in a pre-Investigational New Drug (Pre-IND) meeting, the U.S. Food and Drug Administration (USFDA) agreed upon a clini... Biopharmaceuticals, Neurology, FDA Alpha Cognition, Alzheimer's Disease, amyotrophic lateral sclerosis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 30, 2020 Category: Pharmaceuticals Source Type: news

Two area women are among the first to donate blood plasma in an emergency clinical trial to help treat severely ill patients battling COVID-19
The project is part of the National COVID-19 Convalescent Plasma Project, which the Food and Drug Administration has approved as an Emergency Investigational New Drug (EIND). (Source: SUNY Upstate Medical)
Source: SUNY Upstate Medical - April 18, 2020 Category: Universities & Medical Training Tags: News Coronavirus Source Type: news

Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application
Clinical / Medical (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 16, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Vaccines, Antibodies and Drug Libraries. The Possible COVID-19 Treatments Researchers Are Excited About
In early April, about four months after a new, highly infectious coronavirus was first identified in China, an international group of scientists reported encouraging results from a study of an experimental drug for treating the viral disease known as COVID-19. It was a small study, reported in the New England Journal of Medicine, but showed that remdesivir, an unapproved drug that was originally developed to fight Ebola, helped 68% of patients with severe breathing problems due to COVID-19 to improve; 60% of those who relied on a ventilator to breathe and took the drug were able to wean themselves off the machines after 18...
Source: TIME: Health - April 14, 2020 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 Source Type: news

FDA Accepts IND for NK Cell Therapy CYNK-001 to Treat Patients with COVID-19
The FDA cleared the investigational new drug (IND) application for the use of CYNK-001 in adults with COVID-19. (Source: CancerNetwork)
Source: CancerNetwork - April 3, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news

The FDA is facilitating access to convalescent plasma collected from recovered COVID-19 patients
The FDA is facilitating access to convalescent plasma, antibody-rich blood products that are taken from blood donated by people who have recovered from the COVID-19 virus, that could shorten the length, or lessen the severity, of the illness. The agency will be using multiple pathways to support these efforts and has posted information for investigators wishing to study convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications for individual patients. (Source: World Pharma News)
Source: World Pharma News - March 25, 2020 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

Through the emergency Investigational New Drug (eIND) application process, FDA is facilitating the use of #COVID19 convalescent plasma as an investigational treatment for individual #COVID19 patients with serious or immediately life-threatening #COVID19. https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds   …
Through the emergency Investigational New Drug (eIND) application process, FDA is facilitating the use of #COVID19 convalescent plasma as an investigational treatment for individual #COVID19 patients with serious or immediately life-threatening #COVID19. https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 24, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Sometimes science moves faster than the regulatory process, & in times of public health emergency like the #COVID19 pandemic, it is paramount that we be flexible in getting potentially life-saving investigational medicines to patients who need them most. https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds   …
Sometimes science moves faster than the regulatory process, & in times of public health emergency like the #COVID19 pandemic, it is paramount that we be flexible in getting potentially life-saving investigational medicines to patients who need them most. https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 24, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

ImStem Biotechnology Announces FDA has Lifted the Clinical Hold on the...
ImStem Biotechnology, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and cleared the Investigational New Drug (IND) application to evaluate IMS001 for the...(PRWeb March 20, 2020)Read the full story at https://www.prweb.com/releases/imstem_biotechnology_announces_fda_has_lifted_the_clinical_hold_on_the_investigational_new_drug_application_for_ims001_for_the_treatment_of_multiple_sclerosis/prweb16992369.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - March 20, 2020 Category: Pharmaceuticals Source Type: news

Emergency Investigational New Drug (EIND) Applications for Antiviral Products
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 16, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

First Patient Dosed in Phase I Clinical Trial using RoosterBio ’s...
Investigational New Drug (IND) Using RoosterBio’s CliniControl™ Products Enters the Clinic by RoosterBio’s Pharmaceutical Customer(PRWeb March 04, 2020)Read the full story at https://www.prweb.com/releases/first_patient_dosed_in_phase_i_clinical_trial_using_roosterbios_cellular_starting_materials/prweb16955951.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - March 4, 2020 Category: Pharmaceuticals Source Type: news

Immunotoxicology Evaluation of Investigational New Drugs
This guidance makes recommendations to sponsors of investigational new drugs (INDs) on (1) the parameters that should be routinely assessed in toxicology studies to determine effects of a drug on immune function, (2) when additional immunotoxicity studies should be conducted, and (3) when additional (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications Guidance for Industry
This guidance helps sponsors of investigational new drug applications and applicants of new drug 17 applications evaluate drug-drug interactions (DDIs) during drug development and communicate 18 the results and recommendations from DDI studies. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves IND application for switchable CAR T-cell therapy
Calibr received approval from the FDA to move forward with an investigational new drug to treat relapsed/refractory B-cell malignancies with a switchable CAR T-cell therapy. (Source: CancerNetwork)
Source: CancerNetwork - February 7, 2020 Category: Cancer & Oncology Authors: Matthew Fowler Source Type: news

FDA clears investigational new drug application for Calibr's 'switchable' CAR-T therapy
(Scripps Research Institute) Calibr, the drug discovery and development division of Scripps Research, today announced that the US Food and Drug Administration has given clearance to the Investigational New Drug (IND) application for Calibr's 'switchable' CAR-T cell therapy, which is being evaluated for the treatment of certain cancers, including relapsed/refractory B-cell malignancies such as non-Hodgkin lymphoma and chronic lymphocytic leukemia. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 3, 2020 Category: International Medicine & Public Health Source Type: news

Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment
Assist sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to 19 support marketing approval of drugs and biological products2 for the treatment of specific 20 hematologic malignancies. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 24, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

INHIBITOR Therapeutics Submits Investigational New Drug Application for Treatment of Patients with Late-Stage Prostate Cancer
SUBA™-Itraconazole to be Tested in Combination with Standard of Care Chemotherapy for Metastatic Castrate Resistant Prostate Cancer FDA Confirms the Proposed Study Adequately Addresses the Objectives Necessary to Support a Regulatory Submission TAMPA... Biopharmaceuticals, Oncology, FDA INHIBITOR Therapeutics, SUBA-Itraconazole, prostate cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 25, 2019 Category: Pharmaceuticals Source Type: news

Three UCLA scientists receive grants totaling more than $18 million
Three researchers at the  Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA have received awards totaling more than $18 million from the California Institute for Regenerative Medicine, the state’s stem cell agency. The recipients areDr. Sophie Deng, professor of ophthalmology at the UCLA Stein Eye Institute;  Yvonne Chen, a UCLA associate professor of microbiology, immunology and molecular genetics; andDr. Caroline Kuo, a UCLA assistant clinical professor of pediatrics. The awards were announced at a CIRM meeting today.Deng ’s four-year, $10.3 million award ...
Source: UCLA Newsroom: Health Sciences - October 31, 2019 Category: Universities & Medical Training Source Type: news

Digital submission of adverse event reports for investigational new drug applications
The U.S. Food and Drug Administration is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS). The planned process for submissions is outlined in a new draft guidance, and the FDA is also making available supporting technical specification documents. (Source: World Pharma News)
Source: World Pharma News - October 29, 2019 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

The Importance of Quality Data and Data Fitness in a Regulatory...
This webinar aims to provide guidance and support for those preparing a submission of their Investigational New Drug (IND) to regulatory bodies by exploring Data Quality Oversight (DQO) combined with...(PRWeb October 15, 2019)Read the full story at https://www.prweb.com/releases/the_importance_of_quality_data_and_data_fitness_in_a_regulatory_submission_upcoming_webinar_hosted_by_xtalks/prweb16643428.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - October 15, 2019 Category: Pharmaceuticals Source Type: news

Webinar: Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS)- Nov. 1, 2019
FDA is establishing a new submission process for investigational new drug (IND) safety reports. Submission of this important safety information as structured data will improve FDA ’s ability to review and track safety signals that occur during the conduct of clinical trials. It will also provide spon (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 24, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

DEA Moving on MMJ BioPharma Marijuana Cultivation Application for FDA...
Once awarded, the DEA approval will allow MMJ BioPharma Cultivation to cultivate cannabis plants to support MMJ International Holdings investigational new drug (IND) filings with the FDA for Multiple...(PRWeb August 27, 2019)Read the full story at https://www.prweb.com/releases/dea_moving_on_mmj_biopharma_marijuana_cultivation_application_for_fda_study_supply/prweb16530493.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - August 27, 2019 Category: Pharmaceuticals Source Type: news

"Research Investigational New Drug Applications – What You Need To Know" June 25, 2019 Issue
FDA recently released an update to clarify when ‘Research’ vs. ‘Commercial’ should be selected on FDA Form 1571, and thus when electronic common technical document or “eCTD” requirements would apply for an investigational new drug or “IND” application. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 26, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Incysus Therapeutics receives US patent for its technology
Biopharma company Incysus Therapeutics has been issued a patent by the U.S. Patent and Trademark Office for “Drug Resistant Immunotherapy for treatment of a cancer.”  According to the company, the patent covers the treatment of brain cancer with the combination of certain chemotherapies and a T cell genetically modified to confer chemotherapy resistance.  According to the company, Incysus has two Investigational New Drug applications (INDs) approved by the U.S. Food and Drug Administration… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - June 21, 2019 Category: Health Management Authors: Tyler Patchen Source Type: news

Incysus Therapeutics receives US patent for its technology
Biopharma company Incysus Therapeutics has been issued a patent by the U.S. Patent and Trademark Office for “Drug Resistant Immunotherapy for treatment of a cancer.”  According to the company, the patent covers the treatment of brain cancer with the combination of certain chemotherapies and a T cell genetically modified to confer chemotherapy resistance.  According to the company, Incysus has two Investigational New Drug applications (INDs) approved by the U.S. Food and Drug Administration… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 21, 2019 Category: Biotechnology Authors: Tyler Patchen Source Type: news

Personalized Stem Cells, Inc. Submits Investigational New Drug (IND)...
Personalized Stem Cells, Inc. submits Investigational New Drug (IND) application for the treatment of osteoarthritis with stem cells.(PRWeb June 18, 2019)Read the full story at https://www.prweb.com/releases/personalized_stem_cells_inc_submits_investigational_new_drug_ind_application_for_the_treatment_of_osteoarthritis_with_stem_cells/prweb16384983.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - June 18, 2019 Category: Pharmaceuticals Source Type: news

Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products
Clinical/Medical; Investigational New Drug Applications; Pharmacology/Toxicology (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 11, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings
The purpose of this guidance is to assist sponsors of drug and biological products for the 19 treatment of rare diseases in early development and in the planning of and participation in formal 20 pre-investigational new drug application (pre-IND) meetings with the Food and Drug 21 Administration (FD (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 11, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products. Questions and Answers
Clinical/Medical; Investigational New Drug Applications; Pharmacology/Toxicology (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 11, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Clinical Investigator Inspection List (CLIIL)
The Clinical Investigator Inspection List contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with investigational new drugs. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 5, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Delaware-developed CRISPR cancer therapy edging closer to human testing
Christiana Care Health System ’s Gene Editing Institute is preparing a preliminary investigational new drug (IND) application that, if approved by the Food and Drug Administration, would allow the institute to begin human testing of a CRISPR therapy it is developing to treat non-small cell lung cancer. CRISPR, an acronym for Clustered Regularly Interspaced Short Palindromic Repeats, is a technique that allows researchers to alter DNA sequences and modify gene function. Christiana Care’s Gene… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - May 6, 2019 Category: American Health Authors: John George Source Type: news

FDA Warns Against Using Young Blood As Medical Treatment
(CNN) — Wannabe vampires, beware: The US Food and Drug Administration warned Tuesday against using plasma infusions from young blood donors to ward off the effects of normal aging as well as other more serious conditions. Plasma, the liquid portion of the blood, contains proteins that help clot blood. The infusions are promoted to treat a variety of conditions, including normal aging and memory loss as well as serious conditions such as dementia, multiple sclerosis, heart disease and post-traumatic stress disorder. “There is no proven clinical benefit of infusion of plasma from young donors to cure, mitigate, t...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - February 19, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Offbeat Blood Donations CNN Source Type: news