AAHP 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…
Label 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…
The 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…
AAHP Encourages Clear and Open Communication on Teething Medicines Tragedies
In the interest of public safety, the American Association of Homeopathic Pharmacists (AAHP) encourages the U.S. Food and Drug Administration to provide clear and open communication on their ongoing investigation…
Document Management Systems
It is often said that the pharmaceutical industry produces two products: healthcare products and the paper that goes along with it. During the past 20 years, we have seen a…
What homeopathic manufacturers need to know, and what the FDA wants to see.
By Eric Foxman, AAHP Secretary Late last month, I joined Mark Vermette and Lyn Agostinelli of Halloran Consulting Group as they prepared for our upcoming Compliance Thru Education webinar: Document…
US FDA Establishment Inspections: Outcomes for Labelers for Homeopathic Drugs
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Understanding OTC Monograph Reform: Where Do We Stand Now?
By J.P. Borneman, Ph.D. and Alvin J. Lorman, J.D. The FDA’s Over-the-Counter Drug Review (OTC Review) has always been important to homeopathy, despite the fact that homeopathic drugs are not…
Webinar Review: FDA’s View on Compliance
On May 24, 2016, the American Association of Homeopathic Pharmacists hosted the latest in its Compliance through Education webinar series. The webinar featured a presentation from Brad Pace, acting director…
Homeopathic Drug Labels: Rx or OTC?
By J.P. Borneman, Ph.D. and Alvin J. Lorman Homeopathic drugs, we proudly tell folks, really are drugs: the Federal Food, Drug, and Cosmetic Act has recognized them as such since…
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