— Recall News Alerts —
Drugs: Recently, the FDA’s Office of International Programs (OIP) said it is exploring a single, global drug recall system that would encompass all domestic and international drug recalls.
Devices: Both CDRH and Health Canada plan to issue guidance soon on what evidence acceptably shows that a company’s recalls has been effective. These recall strategies are expected to document supply chain communications down to the patient.
No one can argue that it seems the FDA appears to be taking a tough stance on recall strategy. Are you ready?
Now, more than ever, you need a proactive recall strategy, one that includes the United States and every other country in which your products are sold.
Like it or not — despite the complicated process you have to go through to receive regulatory approval — product recalls are a reality, in the U.S. and in every other country where your product is sold.
Those unprepared will see millions siphoned from their bottom lines — spent on everything from damage control advertisements to public relations experts — with countless man-hours wasted on spin control instead of new product development.
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International Drug and Device Recalls: the 90-minute FDAnews CD and transcript presentation shows you how to craft a master global recall strategy to protect your product from the toughest regulatory storms, at home and abroad — solidly based on the regulations of the FDA, World Health Organization, European Medicines Agency and the Health Protection Branch of Health Canada.
Noted attorney James M. Wood of Reed Smith shares with you his proactive, proven international plan for recalls — each step carefully developed from lessons learned in three decades representing manufacturers of prescription medicines and medical devices. You will complete this CD and transcript presentation with all you need to successfully:
There’s more. International Drug and Device Recalls even gives you situation-specific advice on the “gray areas” of global recalls:
Mr. Wood has received rave reviews from prior FDAnews presentations, including:
"It was well organized. The presenter was prepared and gave good verbal example and gave me ideas on how to improve our recall process."
"Strong internal recalls presentation and good fielding of questions."
No company ever wants to face a recall. But recalls will happen — and an FDA “seal of approval” is no guarantee you’ll escape it.
James M. Wood is a noted attorney with Reed Smith. His practice for 32 years has focused on the representation of manufacturers of prescription medicines and medical devices. He has represented and counseled manufacturers of prescription products involving a variety of issues. These have included recalls of prescription products, marketing and promotion of these products, First Amendment issues in marketing these products, off-label issues, preemption, product liability issues and the reuse of single-use medical devices.
Based on this experience, he has recently co-authored a book that details planning for and implementing the recall process for all regulated products, Prescription Product Recalls — A Proactive Primer. He has also served as regional counsel for an international medical device company in a product liability action and was the multi-district litigation liaison counsel in the Gammagard® MDL litigation.
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