Regulatory

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…

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…

By Mark Land, AAHP President June 4, 2018 FDA docket 2017-D-6580 for comments on the draft guidance for FDA staff and industry entitled “Drug Products Labeled as Homeopathic” closed on Monday, May 21 after a 60-day extension.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…

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…

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…

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…

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…

By Leonard Krause, FDA Connect November 1, 2017 It is that time of year again. Days are getting shorter and colder, and AAHP members who manufacture homeopathic and over-the-counter (OTC) products need to renew their drug manufacturing establishments with U.S. Food and Drug Administration (FDA). This year, however, add one readm more…