Posts by Brian Westerlind
Legal Memo: Overview of Recent Warning Letters
AAHP Counsel, Al Lorman, has prepared a memo with an overview of recent warning letters, especially highlighting issues raised in the group of warning letters to manufacturers of homeopathic products…
Read MoreTwo Additional Topics Expand Continuing Education Program for Pharmacists on Homeopathic Drugs
Topics on colds and flu and calendula were recently launched through Pharmacy Times Continuing Education (PTCE), division of Pharmacy Times®. Pharmacists and pharmacy technicians can receive continuing education credits after…
Read MoreHow to Stop Bad Inspections: It Starts with Staff
By Mark Land, AAHP President At AAHP, we firmly believe that compliance with quality and safety regulations is crucial for all homeopathic manufacturers. To educate our community, we’ve published…
Read MoreOnline Opportunities and Responsibility
By Mark Land, AAHP President As our article on online marketing techniques shows, there’s great opportunity to increase product awareness and sales. But take caution; Do not do so at…
Read MoreHow to Submit Monographs to the HPUS
FDA’s Revised Draft Enforcement Document states the Agency considers only products that use substances monographed in the Homeopathic Pharmacopoeia of the United States (HPUS) as homeopathic. This statement has created interest…
Read MoreFDA Comment Period Extended: Help AAHP Present Manufacturers’ Voice
AAHP is preparing comments to “FDA Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry.” Initially published in December 2017, the guidance was revised and republished…
Read MoreAAHP’s Views on Aspects of FDA’s Revised Draft Guidance
Since 2015, the Food and Drug Administration (FDA) has been engaged in a reevaluation of Compliance Policy Guide 400.400, Conditions under Which Homeopathic Drugs May Be Marketed. FDA issued a…
Read MoreAAHP 2019: Reawakening the Regulatory and Retail Dialog
By Mark Land, AAHP President This year marks the fifth year in a cycle of regulatory review of homeopathic drug product labeling, safety, and quality. AAHP has been there for…
Read MoreTrump Nominates New FDA Commissioner
Senate Hearing Set for Nov. 20 By Pete Evich, AAHP Govt. Relations On Nov. 1, President Trump nominated Stephen Hahn, chief medical executive of the MD Anderson Cancer Center…
Read More4 Types of FDA Inspections & How to Prepare
Risk. It’s a hot word in the homeopathic industry right now. Even before the FDA issued its draft guidance, the agency used a risk-based approach to site inspections. With the…
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