Drugs of Off-Patents, OR Off-Exclusivity without an FDA Approved Generic: 307 Drugs Today (June 18, 2020), the U.S. Food and Drug Administration (FDA) published an updated “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic.” The following list includes approved new drug applications (NDAs) for drug products that are not protected by patents or exclusivities at the time of the
Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices About Emergency Use Authorizations (EUAs) Pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA has authority to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or
Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency FDA has issued a Guidance for Industry entitled “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency.” This guidance provides recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the duration of the COVID-19 public health emergency.
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input The U.S. Food and Drug Administration has issued a methodological guidance (Guidance 1) for industry, FDA staff, and other stakeholders entitled “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input”. To support patient-focused drug development, this guidance addresses both a statutory requirement under the 21st Century Cures Act of 2016 (hereafter referred to as
Lose Dose Corticosteriod (Dexamethasone) Found Effective in Treating COVID-19 According to RECOVERY* trial, it was found that corticosteroid (dexamethasone) reduces death in hospitalized patients with COVID-19. *: a randomised trial investigating whether treatment with either Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Convalescent plasma or Tocilizumab prevents death in patients with COVID-19. In a trial, patients (n=2014) were randomized to receive 6 mg
The US FDA Has Revoked the Emergency Use Authorizations (EUA) of Chloroquine and Hydroxychloroquine to Treat COVID-19 The US FDA Has Revoked the Emergency Use Authorizations (EUA) for emergency use of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) to treat the COVID-19 disease because BARDA concluded, based on clinical trial data results, that the drug’s potential benefits do not outweigh
COVID-19-Related FDA Guidances The following list of FDA guidances provide recommendations to industry regarding biologics, biologics/drugs, biologics/medical devices, drugs, drugs/biologics, biologics/medical devices, medical devices, food & beverages, biologics, drugs and medical devices during a COVID-19 pandemic. These guidances discuss FDA’s intended approach to enforcement of regulatory (compliance) requirements for medical products and dietary supplements during a pandemic. Biologics (with Drugs
Pfizer: Clinical Trials on COVID-19 Pfizer, a multinational biopharmaceucal giant, is testing few drugs on COVID-19. Xeljanz (tofacitinib) In a multicenter, randomized, double-blind, placebo-controlled, parallel study (phase 2), it is currently evaluating the safety and efficacy of tofacitinib in hospitalized adult subjects* (N=240) with COVID-19 pneumonia. *: subjects with lab confirmed SARS-CoV infection as determined by a positive PCR or
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention During the Coronavirus Disease 2019 (COVID-19) pandemic, US Food and Drug Administration (FDA) has issued a guidance to assist sponsors in clinically developing drugs and biological products intended to treat or prevent COVID-19. This guidance doesn’t address preventative vaccines and plasma (convalescent). This guidance is in effect during the COVID-19
Drugs or Vaccines in Phase 2 Clinical Trials in Patients with COVID-19 This is as of June 7, 2020. For the interest of understanding currently ongoing clinical trials for a list of representative drugs in patients with COVID-19, the following provides a list of drugs which are currently being tested in phase II clinical trials. In other words, this is
