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 will fund a clinical tri...
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
