Search results for: gooley

Initiation of Voluntary Recalls: Draft Guidance for Industry and FDA Staff

By Mark Land, AAHP President   Product recalls are an important tool that manufacturers and the U.S. Food and Drug Administration (FDA) use to minimize exposure to potentially harmful or ineffective products.1 Drug product recalls are voluntary — that is to say, FDA does not have legal authority to recall readm more…

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Prepare for Recalls: 5 Crucial Steps

By Ryan Gooley, Recall Consultant, Stericycle   Recalls impact thousands of companies every year, and they represent serious risk for the brands impacted. Homeopathic recalls, especially those involving products meant for children or the elderly, can cause widespread media coverage and consumer panic, potentially flooding call center phone lines and readm more…

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Recall Preparedness

By Mark Land, AAHP president November 20, 2017 Risks associated with the therapeutic use of healthcare products are real. Manufacturers and the U.S. Food and Drug Administration (FDA) balance these risks all of the time when making marketing authorization decisions. These risks can be evaluable or unanticipated. Evaluable risks from readm more…

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Webinars

Webinars The AAHP Education Committee presents in-person seminars and real-time webinars. Participants include industry members, scientists, attorneys, regulators and other industry associations. Attendees benefit from first-hand knowledge of important scientific, legal and regulatory information and receive valuable tools including checklists, forms, and templates for use within their companies. Educational programs are also available on DVD…

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