COVID-19: Critical Issues Facing the United States and the World

December 2, 2020 | Live 11:00am EST / 9:00am PST / 16:00 GMT / 17:00 CET  
Online Live 

WEBINAR: COVID-19: http://ow.ly/yxKU50Cuzaq A must for anyone in the regulatory field both in industry and local, state and federal government. #FDA#FDAlaw#covid#webinar#cfpatraining

Webinar presented by: Roseann TerminiCOVID-19: Critical Issues Facing the United States and the World

COVID-19: Critical Issues Facing the United States and the World

This 60-minute accredited webinar will cover the following:
– Overview of Key Terminology-impact of COVID-19 
– Numbers Surge and Direction from the Federal Government
– Update on Diagnostics
– Controversy over Telethermographic Systems (Body Temperature Assessment)
– Science vs. Politics
– EUA Recent and Horizon
– Efficacy
– COVID-19 Approval
– Immunity
– Tracing, Tracking
– Impact of the Executive Order regarding Slaughterhouses
– Lessons Learned Globally
– Known and Unknowns
– Solutions

In-Person Course

Who Should Attend?
This course is a must for anyone in the regulatory field both in industry and local, state and federal government: 
– Regulatory affairs
– Quality assurance and control
– Drug representatives
– Managers
– Sales personnel
– Manufacturers
– Physicians
– Pharmacists
– Health care providers and practitioners
– Attorneys, In house counsel
– Risk managers; enforcement personnel; and compliance teams 

COVID-19 Impact on the Regulated Industry and Regulators

COVID-19-Impact on the Regulated Industry

COVID-19-Impact on the Regulated Industry
Date: November 18, 2020 
Time: Live 12:00pm (EST) / 9:00am (PST) / 17:00 (GMT) / 18:00 (CET)
Location: Webinar/Online

Join us for a unique opportunity to find out more about the COVID-19 pandemic in this nearly daily changing landscape. What you think applies today might change drastically tomorrow. This webinar will explore recent FDA activity regarding COVID-19 including an upcoming program discussion on inspections and other enforcement methods in the COVID-19 ERA. This is a Free CfPA Exclusive FREE Webinar.

Can’t make the LIVE webinar? Register now and we’ll send you a copy of the recording.

Registration Link: https://www.cfpa.com/CourseDescription/CourseDescription/2011907OL2974L/2974?utm_source=Listrak&utm_medium=Email&utm_term=Register+Now_2974&utm_campaign=2947_Free_1


Presented by: Roseann B. Termini, B.S., Ed. M., J.D. 
Ms. Termini has extensive experience in food, drug, medical devices, personal care, dietary supplement, tobacco and veterinary products regulation. Ms. Termini recently published a new comprehensive edition, both in print and E-book formats, of Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products (2019). Ms. Termini is also a featured speaker at international and national conferences and webinars.

FDA COVID-19 Treatment Approval

First FDA Approval for COVID-19: Veklury (remdesivir), an antiviral drug, manufactured by Gilead. It is for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. 

The FDA granted Gilead’s application Fast Track and Priority Review designations. Further FDA granted this application a  Material Threat Medical Countermeasure Priority Review Voucher. This means additional incentives because COVID-19 falls within this category; that is, medical products intended to treat or prevent harm from specific chemical, biological, radiological and nuclear threats. It is important to mention that this approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) (issued on May 1, 2020). 

NOTE—FDA had granted Gilead Sciences Orphan Drug status for remdesivir and orphan designation for the “Treatment of coronavirus disease 2019 (COVID-19)” (March 23, 2020) which means tax advantages and exclusivity; however, in an unusual twist,  Gilead requested on March 25, 2020 that FDA rescind orphan drug designation.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19

https://www.gilead.com/news-and-press/press-room/press-releases/2020/10/us-food-and-drug-administration-approves-gileads-antiviral-veklury-remdesivir-for-treatment-of-covid19

COVID-19, CBD, VAPING, PET PRODUCTS SAFETY, OPIOID EPIDEMIC

This week, on Wednesday October 21, from 1-4pm, the FDLA, Delaware Law will be virtually hosting its “All Matters FDA” Symposium which will host a variety of speakers from professors, to judges, to other professionals in the field to discuss a range of topics such as: opioids and pharmaceuticals, COVID-19, vaping, cannabis law, and pet products. Just follow the link below to register. Even if you can only attend in part we hope you will be able to join us!   If you register and have a conflict the session will be recorded.

The Symposium will be hosted over zoom, and a link will be sent out beforehand.

Even if you can only attend in part we hope you will be able to join us!   If you register and have a conflict the session will be recorded.

TOBACCO CONTROL ACT AND THE PRESENT-DAY IMPACT ON “OVERLOOKED AND BELATED ISSUES”—ENDS, YOUTH EPIDEMIC, GRAPHIC WARNINGS

Abstract

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3311583

Although smoking has plagued the United States for generations, it was not until the past several years that smoking received more serious scrutiny. Yet, the reality is that as far back as the 1960s, tobacco products posed a serious threat to human health as evidenced by the Surgeon General’s report explaining that smoking causes cancer.  

Fast forward to current times, the Centers for Disease Control (“CDC”) has determined that over 1,300 people in the United States die each day due to smoking and over sixteen million Americans have a disease attributed to smoking. The CDC concluded that in the United States, cigarette smoking is responsible for more than 480,000 deaths annually, and secondhand smoke exposure caused more than 41,000 of these deaths.  

These statistics do not just cover the older generations that many associate with smoking. Over the years, the numbers in teen smoking statistics have escalated since the 1990s. Based on CDC statistics, about 2,000 youth start smoking their initial cigarette, and 300 youth become day-to-day smokers. This means that using current rates of smoking among youth, 5.6 million Americans younger than eighteen years of age are expected to die prematurely from a smoking-related illness. This denotes about 1 in every 13 Americans aged seventeen years or younger who are alive today. The Center for Tobacco Products (“CTP”) within the United States Food and Drug Administration (“FDA”) regulates tobacco products with a mission of diminishing tobacco related deaths and diseases. Since its creation, the CTP has maintained a critical mission on educating youth about the dangers of smoking. Yet, teen use of tobacco related products has increased.  

The Family Smoking Prevention and Tobacco Control Act (FSPTCA or Tobacco Act) became law on June 22, 2009. This legislation conferred authority to the FDA to regulate tobacco products. The FSPTCA amended the Food, Drug, and Cosmetic Act (FDCA) and other federal laws by permitting FDA regulatory authority over of tobacco products. This includes cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Yet, the FSPTCA, when enacted, was silent on issues of e-cigarettes and other electronic nicotine delivery systems (ENDS) and were eventually “deeming” as part of the FSPTCA. 

There are a myriad of matters concerning tobacco products regulation. However, this article highlights critical issues important to the public health in the United States. This article provides an overview of tobacco products regulation, including the FSPTCA. Yet, issues persist such as undue delay in reissuing graphic warnings for cigarettes and lengthy legal battles over the language used in court-ordered corrective statements. Further, the FSPTCA was silent on other tobacco products besides traditional cigarettes such as cigars, pipe tobacco and ENDS including e-cigarettes. To overcome the lack of inclusion in the FSPTCA, deeming regulations were enacted. Despite the deeming regulations, the use of tobacco products, including vaping and e-cigarettes, has escalated. Finally, this article discusses the FDA’s accomplishments along with further recommendations to stem the rise in youth use of e-delivery products. 

Keywords: Tobacco Regulation, E-Cigarettes, Family Smoking Prevention and Tobacco Control Act, Food and Drug Administration, Electronic Nicotine Delivery Systems, Youth Smoking

Medical Device Safety—This Is Not 1976 Anymore Moving Forward: The 510(K) Clearance Process Under the U. S. Food, Drug, and Cosmetic Act

Check out my latest article: Medical Devices —This Is Not 1976 Anymore — Moving Forward— Safety and the 510(K) Clearance Process Under the Food, Drug, and Cosmetic Act https://linkedin.com/pulse/medical-devices-1976-anymore-moving-forward-safety-510k-termini… via @LinkedIn

A Look Back Evolution of the Family Smoking Prevention and Tobacco Control Act —Present-Day Impact on ‘Overlooked and Belated Issues’ — Electronic Nicotine Delivery Systems and the Youth Epidemic, Menthol, Graphic Warnings and Corrective Statements

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3311583

Although smoking has plagued the United States for generations, it was not until the past several years that smoking received more serious scrutiny. Yet, the reality is that as far back as the 1960s, tobacco products posed a serious threat to human health as evidenced by the Surgeon General’s report explaining that smoking causes cancer.  

Fast forward to current times, the Centers for Disease Control (“CDC”) has determined that over 1,300 people in the United States die each day due to smoking and over sixteen million Americans have a disease attributed to smoking. The CDC concluded that in the United States, cigarette smoking is responsible for more than 480,000 deaths annually, and secondhand smoke exposure caused more than 41,000 of these deaths.  

These statistics do not just cover the older generations that many associate with smoking. Over the years, the numbers in teen smoking statistics have escalated since the 1990s. Based on CDC statistics, about 2,000 youth start smoking their initial cigarette, and 300 youth become day-to-day smokers. This means that using current rates of smoking among youth, 5.6 million Americans younger than eighteen years of age are expected to die prematurely from a smoking-related illness. This denotes about 1 in every 13 Americans aged seventeen years or younger who are alive today. The Center for Tobacco Products (“CTP”) within the United States Food and Drug Administration (“FDA”) regulates tobacco products with a mission of diminishing tobacco related deaths and diseases. Since its creation, the CTP has maintained a critical mission on educating youth about the dangers of smoking. Yet, teen use of tobacco related products has increased.  
The Family Smoking Prevention and Tobacco Control Act (FSPTCA or Tobacco Act) became law on June 22, 2009. This legislation conferred authority to the FDA to regulate tobacco products. The FSPTCA amended the Food, Drug, and Cosmetic Act (FDCA) and other federal laws by permitting FDA regulatory authority over of tobacco products. This includes cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Yet, the FSPTCA, when enacted, was silent on issues of e-cigarettes and other electronic nicotine delivery systems (ENDS) and were eventually “deeming” as part of the FSPTCA. 

There are a myriad of matters concerning tobacco products regulation. However, this article highlights critical issues important to the public health in the United States. This article provides an overview of tobacco products regulation, including the FSPTCA. Yet, issues persist such as undue delay in reissuing graphic warnings for cigarettes and lengthy legal battles over the language used in court-ordered corrective statements. Further, the FSPTCA was silent on other tobacco products besides traditional cigarettes such as cigars, pipe tobacco and ENDS including e-cigarettes. To overcome the lack of inclusion in the FSPTCA, deeming regulations were enacted. Despite the deeming regulations, the use of tobacco products, including vaping and e-cigarettes, has escalated. Finally, this article discusses the FDA’s accomplishments along with further recommendations to stem the rise in youth use of e-delivery products. 

Keywords: Tobacco Regulation, E-Cigarettes, Family Smoking Prevention and Tobacco Control Act, Food and Drug Administration, Electronic Nicotine Delivery Systems, Youth Smoking