Regulatory
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…
Read MoreLegislative Update: Actions Since FDA’s Draft Guidance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)…
Read MoreUnited 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…
Read MoreSteps 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…
Read MoreRecall 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…
Read MoreAnnual Certification of Drug Product Listings
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)…
Read MoreWhat’s New at FDA?
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…
Read MoreThe Road to OTC Monograph Reform
By Barbara A. Kochanowski, senior vice president of regulatory and scientific affairs Consumer Healthcare Products Association August 1, 2017 For the past three years, the regulated industry has been working…
Read MoreFDA’s Division of Nonprescription Drug Products
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…
Read MoreOTC Monograph Reform
By Mark Land, AAHP president August 1, 2017 Self-medication is an important way in which American consumers treat many types of illnesses. Over-the-counter (OTC) drugs often provide effective relief in…
Read More