Regulatory

A Brief Regulatory History of Process Validation

By Mark Land, AAHP President   Finished product testing is probabilistic and not dispositive of process control; that is why we need process validation. While preparing this article I came across several histories of process validation. One that caught my attention was a book chapter written by Bernard Loftus, formerly 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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Crystal Ball: 2018 Federal Election

By Pete Evich, AAHP government relations “It’s tough to make predictions, especially about the future.” ― Yogi Berra With the mid-term federal elections almost five months down the road, it’s high-season for those of us in the business of Congress-watching to prognosticate what is likely to transpire this November. Five readm more…

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AAHP Rouses 38,000 Letters to Capitol Hill and Garners Congressional Support

As the result of the AAHP’s first grassroots effort, 38,000 letters from consumers and health care providers poured into offices of U.S. senators and representatives this spring. The letter-writing campaign urged Congressional leaders to ask the U.S. Food and Drug Administration (FDA) to incorporate key elements of the 1988 guidance regulating homeopathic readm more…

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How Much Can Machine Learning Help Us?

By Mark Land, AAHP President June 4, 2018 FDA docket 2017-D-6580 for comments on the draft guidance for FDA staff and industry entitled “Drug Products Labeled as Homeopathic” closed on Monday, May 21 after a 60-day extension. There were 4,792 comments submitted to the docket. That was about half the readm more…

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AAHP Speaking Tour

By Mark Land, AAHP President April 24, 2018 Since the beginning of the year I have embarked on a tour to inform the community of AAHP’s position on the FDA’s draft guidance, Drug Products Labeled as Homeopathic, and understand the issues on the minds of our community members. During this readm more…

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Legislative Update: Actions Since FDA’s Draft Guidance

By Pete Evich, AAHP government relations March 1, 2018 Given AAHP’s concerns with the omissions of key homeopathic references and definitions in the United States Food and Drug Administration’s (FDA) December 2017 draft homeopathic guidance, AAHP has instituted a Capitol Hill strategy to draw attention to the document’s deficiencies. The readm more…

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United States Food and Drug Administration – Good Guidance Practices

By Mark Land, AAHP president February 1, 2018 The Food and Drug Administration (FDA) amended its administrative regulations to codify its policies and procedures for the development, issuance, and use of guidance documents in September 2000.1 This action was necessary to comply with requirements of the Food and Drug Administration readm more…

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Steps Toward Building Grassroots Support

December 6, 2017 Since the FDA hearing and the FTC workshop in 2015, the homeopathic industry has received more attention than usual from regulators. While AAHP continually meets with congressional leaders in Washington and works with both agencies, your association is also working to mobilize stakeholders. It’s important for legislators 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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