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FDA Basics Webinar: Recall Process for FDA-Regulated Products
Consumers are impacted by FDA-regulated products daily. Food, medicines, and medical devices are examples of FDA-regulated products. What happens when a potentially harmful item is on the market?
Learn more on Thursday July, 26, 2012 at 3 p. m. ET, in a FDA- hosted webinar ” Recall Process for FDA-Regulated Products.” Recall Coordinator Cecilia Wolyniak of FDA’s Office of Enforcement will discuss the recall process and how recalls are monitored and publicized.
For more information on how to join the webinar, please visit the FDA Basics section of the website. There are a limited number of spots available. Webinar Slides can viewed before the presentation. Archived material will be available immediately after.
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Upcoming Event: FDA Webinar on Prescription Drug Shortages, September 30, at 11am ET.
Do you know that in 2010 there were a record number of shortages of prescription drugs, and that in 2011, FDA continues to see an increasing number of shortages, especially those involving older sterile injectable drugs?
As part of FDA Basics, FDA is hosting a webinar where you can learn how the agency helps reduce the impact of drug shortages for patients and our nation’s health care system. Captain Valerie Jensen, R.Ph., Associate Director for FDA’s Center for Drug Evaluation and Research’s (CDER’s) Drug Shortage Program, will discuss the extent of the current drug shortage issue and the importance of communication among FDA, drug manufacturers, health professionals, and the public, in helping to reduce its impact on public health.
The free 30 minute webinar will be held Friday, September 30m, at 11 am ET.
There are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA website following the presentation.
Learn more about the webinar, including instructions about how to join the webinar.
Upcoming Event: FDA Basics Webinar on Foreign Inspections, May 17, 2011, at 12:30pm ET
Did you know that FDA foreign inspections have doubled since 2008? Did you know that foreign food inspections alone have quadrupled since 2010?
As part of FDA Basics, FDA is hosting a webinar on foreign inspections where you can learn more. Susan Laska, the Deputy Director of the Division of Foreign Field Investigations, will give an overview and answer questions about FDA’s Global Inspection program.
The free 30 minute webinar will be held Tuesday May 17, 2011 at 12:30 pm ET.
There are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA website following the presentation.
Learn more about the webinar, including instructions about how to join the webinar.
Ann Witt, Transparency Initiative Coordinator
Upcoming Event: FDA Basics Webinar by the Center for Drug Research and Evaluation on the Bad Ads Program, April 28, 2011, at 12 Noon ET
Did you know that healthcare providers can play an important role in ensuring that prescription drug advertising and promotion is truthful by recognizing and reporting misleading ads?
As part of FDA Basics, FDA is hosting a webinar where you can learn more. Catherine Gray, Pharm.D., in the Division of Drug Marketing, Advertising, and Communication (DDMAC) in FDA’s Center for Drug Research and Evaluation will present an overview of the FDA’s “Bad Ad” program, specifically focusing on how to identify misleading prescription drug promotion and report this activity to the agency.
The free 30 minute webinar will be held Thursday, April 28 at 12 noon ET.
There are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA website following the presentation.
Learn more about the webinar, including instructions about how to join the webinar.
Ann Witt, Transparency Initiative Coordinator
Materials Available from FDA Basics Webinar on the FDA’s Center for Tobacco Products State Enforcement Program
Did you miss the FDA Basics webinar about FDA’s Center for Tobacco Products State Enforcement Program? FDA is contracting with states and U.S. Territories to help with compliance and enforcement activities in order to limit the availablity of tobacco products to young people.
Materials from the webinar are now available on the FDA Basics website.
Check out the “What’s New” tab on the FDA Basics homepage to download materials from the webinar. We have posted a link to view and listen to the 30 minute webinar and posted a link to download a copy of the presentation slides.
You can find materials from past FDA Basics webinars here.
Afia Asamoah, Transparency Initiative Coordinator
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Materials Available from FDA Public Webinar About the “510(k) Premarket Review Process” and the “Use of Science in Regulatory Decision Making” Draft Reports
Did you miss the FDA webinar discussion on the draft reports about the 510(k) process and the use of science in regulatory decisions?
The webinar was discussed in a August 26, 2010 blog post. An audiofile of the discussion, along with the background materials, is available on the CDRH website. You can listen to the discussion here.
FDA is soliciting comments from the public on the draft reports via www.regulations.gov, docket number FDA-2010-N-0348, until October 4, 2010.
Afia Asamoah, Transparency Initiative Coordinator
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Upcoming Event: FDA Public Webinar About the “510(k) Premarket Review Process” and the “Use of Science in Regulatory Decision Making” Draft Reports, Tuesday, August 31, 1:00 p.m. ET
FDA recently published two preliminary reports conducted by the Center for Devices and Radiological Health (CDRH). The first preliminary report is an assessment of the process used to review certain medical device applications before they are marketed (known as the 510(k) process) and draft recommendations. The second preliminary report is an assessment of the use of science in CDRH's regulatory decision making and draft recommendations. This is the first step in determining what, if any, improvements to these processes FDA may implement.
Next week, FDA is hosting a webinar where CDRH officials will discuss the details of both reports. There will be an opportunity to ask questions.
The live webinar will be held on Tuesday, August 31, at 1:00 p.m. ET.
There are a limited number of spots available for the webinar. Click here for more information about the webinar, which includes a link to join the webinar on August 31.
FDA is also soliciting comments from the public on the draft reports via www.regulations.gov, docket number FDA-2010-N-0348.
Afia Asamoah, Transparency Initiative Coordinator
