Regulatory

By Mark Land, AAHP President June 4, 2018 FDA docket 2017-D-6580 for comments on the draft guidance for FDA staff and industry entitled “Drug Products Labeled as Homeopathic” closed on…

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)…

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…

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…

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…

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)…

By Mark Land, AAHP president September 1, 2017 I took a course several years ago titled Regulatory Intelligence. The first thing the professor said was, “This course is not designed…

By Mark Land, AAHP president August 1, 2017 The development and regulation of over-the-counter (OTC) drug products is the responsibility of the Division of Nonprescription Drug Products (DNDP) within the…