FDA Regulatory Doctor

15
Jul

Regulatory Submissions for Medical Devices

Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry and Food and Drug Administration Staff July 15, 2020 The US Food and Drug Administration (FDA or the Agency) has issued final guidance entitled “Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions

Read more

11
Jul

Aducanumab 221AD302

Aducanumab As a Treatment for Alzheimer’s Disease (AD) Aducanumab Aducanumab (aka BIIB037) is a high-affinity, recombinant, fully human anti-Aβ IgG1 monoclonal antibody (mAb) that recognizes a neoepitope of disease-associated proteins (e.g., a disease specific variant of an endogenous protein) which derive from a native endogenous protein but are prevalent in the body of a patient in a variant form and/or

Read more

8
Jul

Personal Protective Equipment PPE

Personal Protective Equipment (PPE) The United States Food and Drug Administration FDA regulation: 21 CFR 878.4040 Surgical Apparel Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods,

Read more

7
Jul

Rapid Expert Consultations on the COVID-19 Pandemic

Evaluating Data Types A Guide for Decision Makers using Data to Understand the Extent and Spread of COVID-19 (2020) National Academies of Sciences, Engineering, and Medicine (NASEM) has released a guide entitled “A Guide for Decision Makers using Data to Understand the Extent and Spread of COVID-19.” This rapid expert consultation provides insight into the strengths and weaknesses of the

Read more

7
Jul

NASEM Released the Clinical Utility of Compounded Bioidentical Hormone Therapy

The Clinical Utility of Compounded Bioidentical Hormone Therapy A Review of Safety, Effectiveness, and Use (2020) The National Academies for Science, Engineering and Mathematics (NASEM) has released, dated July 1, 2020, its report on compounded bioidentical hormone therapy (cBHT or BHRT). Chapter 9 includes “Clinical Utility and Recommendations” in this report.  Download PDF below. The U.S. Food and Drug Administration (FDA)

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