FDA Basics Webinar December 11th: 20 Years Later – Returning to FDA to Regulate Tobacco

September 17, 2013 20 comments

You may know that Mitch Zeller became the Center for Tobacco Products’ (CTP) Director in March 2013.  What you may not know is that he has been working on FDA issues for 30 years!  Consider this your invitation to learn even more about CTP’s new director, via a special FDA Basics webinar on December 11, 2013.

In the webinar, you will learn more about Director Zeller’s background and hear his thoughts on key opportunities for FDA to help reduce the burden of tobacco through product regulation.  The webinar will be moderated by CTP’s Director of Health Communication and Education, Kathy Crosby, and will allow for questions and answers at the end of the presentation.

Who:  The FDA’s Center for Tobacco Products will host the webinar.

  • Moderator:  Kathy Crosby – Director, Office of Health Communication and Education, Center for Tobacco Products
  • Featured Speaker:  Mitch Zeller, J.D. – Director, Center for Tobacco Products

When: Wednesday, December 11, 2013 at 2:00 p.m. EST (previously scheduled for October 9th)

How to Join:  To participate in the live webinar online, please:

To prepare you for what will unfold in the webinar, take a look at CTP’s goals and priorities and start thinking of any questions you may want to ask Mr. Zeller.

CTP’s tobacco product regulation public health goals:

  • Prevent youth tobacco initiation
  • Encourage adults who use tobacco to quit
  • Reduce product harms and addictiveness
  • Develop a science base and continue meaningful product regulation to reduce the toll of tobacco-related disease, disability and death

As you can see, CTP has a lot of information to share with you. So book this date and time in your calendar now—Wednesday, December 11, 2013 at 2:00 p.m. EST — and don’t miss what is sure to be an informative presentation!

We’ll be taking questions you may have for our Director ahead of time via our Twitter account @FDATobacco or email.  Webinar participants will also have the unique opportunity to ask Mitch Zeller questions live during the event.  Please be sure to include your name and affiliation when asking a question.

CBER’s Direct Recall Classification Program Webinar: Materials Available

July 30, 2013 11 comments

Thank you to all who were able to participate in FDA’s July 25th webinar that explained the Direct Recall Classification (DRC) program and its importance to consumers.  Laura Hieronymus, Senior Recall Coordinator with the Office of Compliance and Biologics Quality in FDA’s Center for Biologics Evaluation and Research, discussed the importance of timely recall information for consumers and the impact DRC has had on speeding up the information flow between industry and FDA.

For those unable to attend, presentation slides and an archived version of the presentation is available on the FDA Basics website.

Thank you again and we hope you are able to join us for the next FDA Basics webinar!

Upcoming Webinar Thursday, July 25 – CBER’s Direct Recall Classification Program

July 22, 2013 11 comments

Do you know the vital role that FDA plays in product recalls and how the Direct Recall Classification program gets recall information to consumers in a more timely manner?

Consumers are impacted by FDA-regulated products every day. Conducting a recall is an effective way for a firm to remove or correct a violative, and possibly dangerous, product from the market. FDA advises firms on their recall strategies and monitors their recall to determine whether it is effective. FDA also publicizes recalls so consumers and health professionals can find out what types of products are being recalled.

On Thursday, July 25th, FDA will host a webinar that explains the Direct Recall Classification (DRC) program and its importance to consumers. Laura Hieronymus, Senior Recall Coordinator with the Office of Compliance and Biologics Quality in FDA’s Center for Biologics Evaluation and Research, will discuss the importance of timely recall information for consumers and the impact DRC has had on speeding up the information flow between industry and FDA.

After the presentation, there will an opportunity to ask questions.

To join the meeting July 25th:

Click the following URL – https://collaboration.fda.gov/r92694857/1
(or cut and paste it into your internet browser).
Click the “Enter as a Guest” button, fill in your name, then click “Enter Room.”
You will need computer speakers to listen to the webinar. Closed captioning will be available.

There are a limited number of spots available for the webinar. Materials from the webinar will also be available on the FDA web site.

FDA Basics Webinar, June 17, 2013: Biological Products, Part 1

June 12, 2013 39 comments

Many of today’s important medications are biological products, generally derived from living material from humans, animals, or microorganisms. These products treat conditions such as rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, and various forms of cancer. Unlike other drugs known as small molecule drugs, biological products are generally highly complex in structure. This webinar is designed to provide an overview of biological products and how they differ from small molecule drugs. Information from this webinar provides helpful background for an enhanced understanding of a future FDA Basics webinar, scheduled for August 19, 2013, on “Biosimilar Biological Products.” Biosimilar biological products or biosimilars are biological products that are similar to or interchangeable with another FDA-approved biological product. In 2010, the Obama Administration passed the Biologics Price Competition Innovation Act, designed to encourage the development of biosimilar biological products which can enhance competition and may lead to better patient access and lower cost to consumers.

Adobe Connect Webinar Information:

Meeting Name: FDA Basics Biologics Webinar
When: June 17, 2013 1:00 PM – 2:00 PM
Time Zone: (GMT-05:00) Eastern Time (US and Canada)

To join the meeting: https://collaboration.fda.gov/basic0617/

You will need computer speakers to listen to the webinar. Closed captioning will be available.  There are a limited number of spots available for the webinar. Materials from the webinar will also be available after the Webinar on the FDA website

We hope you are able to join us!

Upcoming Webinar Thursday, May 30 – Picnic Food Safety, How safe is your picnic?

May 29, 2013 13 comments

Picnics are a great way to enjoy the outdoors but did you know that warm weather increases opportunities for foodborne illness?  On Thursday, May 30, 2013 at 1:00PM ET FDA will host a webinar titled, “Picnic Food Safety.”  Nadine M. Shaw, of FDA’s Center for Food Safety and Applied Nutrition, will share tips on how to ensure a safe picnic.

Webinar Slides: Picnic Food Safety (PDF, 243KB)

To join the webinar: Click the following URL:

1. https://collaboration.fda.gov/r74a7a44v1i/2 (or copy and paste the URL into your internet browser).

2. Click the “Enter as a Guest” button, fill in your name, then click “Enter Room”.

You will need computer speakers to listen to the webinar. Closed captioning will be available.  There are a limited number of spots available for the webinar. Materials from the webinar will also be available after the Webinar on the FDA website

We hope you are able to join us!

Upcoming Webinar Tuesday, March 19th – Buyer Beware:The Risks and Dangers of Purchasing Drugs Online

March 13, 2013 19 comments

Who really operates online pharmacies and where do the drugs come from?

On Tuesday, March 19th, at 2pm EST, FDA will host a webinar addressing how the agency’s Office of Criminal Investigations protects our public health by investigating and bringing to justice individuals who seek to profit from selling substandard or counterfeit drugs to U.S. consumer via seemingly legitimate online pharmacies. Special Agent Daniel Burke, the Senior Operations Manager in Charge of Cybercrime Investigations for the Office of Criminal Investigations will detail several recent investigations and highlight how FDA is leveraging international partnerships as a tool in fighting transnational organized crime networks on the internet.

To join the webinar:

1. Click the following URL: https://collaboration.fda.gov/buyerbeware/ (or copy and paste the URL into your internet browser).

2. Click the “Enter as a Guest” button, fill in your name, then click “Enter Room.”

You will need speakers to listen to this webinar. Closed captioning will be available.

There are a limited number of spots available for the webinar. Materials from the webinar will also be available on the FDA website.

FDA Basics Webinar: A Brief Overview of Risk Evaluation and Mitigation Strategies (REMS)

October 23, 2012 53 comments

In 2007, a new law that gave FDA many new authorities and responsibilities to enhance drug safety was enacted. It’s called the Food and Drug Administration Amendments Act- sometimes called “FDAAA”- and one of its provisions gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.

A REMs may be required by the FDA as part of the approval of a new product, or for an approved product when new safety information arises. Essentially, a REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.

Since medicines are very different from each other, each REMS for each medicine is also different.

This presentation will be held on November 20, 2012 at 1:00 PM EST and will discuss REMS and how they are used to help ensure that the benefits of certain medicines continue to outweigh their risks.  To join the meeting, click here:  https://collaboration.fda.gov/rems1/

For more information, visit the FDA Basics website.

Follow

Get every new post delivered to your Inbox.

Join 149 other followers

%d bloggers like this: