FDA Regulatory Consulting and Training Services

6
Jun

Drugs or Vaccines Being Tested in Patients with 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

Read more

3
Jul

Myelodysplastic Syndrome MDS APR-246 eprenetapopt P53

Myelodysplastic Syndromes (MDS) Myelodysplastic syndromes (MDS) are a heterogeneous group of clonalstem cell malignancies in which bone marrow fails to produce healthy blood cells. MDS is characterised by ineffective and dysplastic myeloid cell differentiation and a high rate of progression (30-40%) to acute myeloid leukaemia (AML).  AML and MDS are generally manifested by an excess of immature or dysfunctional blood

Read more

30
Jun

FDA Guidance Compliance Dates for UDI Requirements

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking FDA Guidance for Industry and Food and Drug Administration Staff Today (June 30, 2020), the U.S. Food and Drug Administration (FDA) issued the guidance entitled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices

Read more

29
Jun

COVID-19 Vaccine

Vaccine against Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)  Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is responsible for the COronVIirus Disease 2019 (COVID-19) pandemic.    The UK drug manufacturer AstraZeneca has partnered with the University of Oxford to develop the adenovirus-vectored vaccine against SARS-CoV-2. An investigational adenovirus-vectored vaccine (ChAdOx1 nCoV-19: AZD1222) against SARS-CoV-2 is currently being tested in phases 2/3 clinical trials.

Read more

25
Jun

FDA Cleared First Video Game to Treat Children with ADHD

Endeavor: Digital Therapeutic (the First Prescription Non-Drug Treatment) to Improve Attention in Children with ADHD Delivered Through an Action Video Game The US Food and Drug Administration (FDA) cleared the first digital prescription attention treatment device (EndeavorRx™: prescription-only game-based device) to improve attention in pediatric patients ages 8 to 12 years old  with attention deficit hyperactivity disorder (ADHD) delivered through

Read more

23
Jun

Nine Toxic Hand Sanitizers by FDA

Nine Brands of Toxic Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol)  The US Food and Drug Administration determined that samples of hand sanitizers, Lavar Gel and CleanCare NoGerm, contain methanol (wood alcohol), a toxic substance when absorbed through the skin or ingested. Methanol should not be used as an ingredient in hand sanitizers due to its toxic

Read more

18
Jun

Drugs without an Approved Generic

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

Read more

18
Jun

COVID-19 EUA

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

Read more

17
Jun

Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency

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. 

Read more

16
Jun

Patient-Focused Drug Development

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

Read more

16
Jun

A Breakthrough Drug to Treat COVID-19

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

Read more