What About Your APIs and Q7 Requirements?
By Eric L. Foxman, R.Ph. Jan. 26, 2017 In September 2016, the U.S. Food and Drug Administration (FDA) issued a guidance document, entitled Q7 Good Manufacturing Practice Guidance for Active…
Read MoreThe European Pharmacopeia and How U.S. Manufacturers Can Use It
By Mark S. Phillips, Pharm. D. Jan. 26, 2017 On Jan. 1, 2017, the 9th edition of the European Pharmacopoeia (Ph. Eur.) became legally binding in its 37 European member…
Read MoreRegulatory Policy Analysis
A Tool for Evaluating the Regulatory Framework for Homeopathic Drug Products By Mark Land, AAHP President Today the combination of drug regulations, approval options, cost controls and societal health care…
Read MoreWho Regulates Your Product Labels?
Does the U.S. Food and Drug Administration (FDA) regulate homeopathic product labels? Or does the U.S. Federal Trade Commission (FTC)? Is it both? While most members of the homeopathic industry…
Read MoreA Trump Administration and a Republican-Controlled Congress
An Assessment and Outlook of the Political and Regulatory Climate for 2017 By Pete Evich, AAHP government relations January 1, 2017 The election of Donald Trump and a Republican-controlled Congress…
Read More2016 Year-In-Review
As 2016 comes to a close and we think back on all the many amazing and unexpected things that have happened, we also note the many activities undertaken and accomplishments…
Read MoreAAHP Compliance Thru Education Webinar on FDA Inspections
The association just completed another successful Compliance Thru Education webinar: FDA Inspections of Homeopathic and Drug Manufacturing Facilities: An Agency View. This webinar, held on Dec. 1, was the last…
Read MoreLabel Comprehension Studies for Nonprescription Drug Products
The Food and Drug Administration (FDA) sometimes requires sponsors to conduct label comprehension studies that are designed to evaluate proposed nonprescription drug product labeling. A label comprehension study assesses the…
Read MoreUpcoming Webinar to Address FDA Inspections of Homeopathic Manufacturing Facilities
MILWAUKIE, Ore. (November 22, 2016) – The American Association of Homeopathic Pharmacists’ (AAHP) newest educational webinar will take place on Thursday, Dec. 1, 2016 at 1:00 p.m. EST and will…
Read MoreThe Importance of Standard Operating Procedures
By Mark Land, AAHP President Manufacturers of health care products rely on precision, rigor and consistency to produce reliable products for patients, physicians and consumers time and again. To drive…
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