Compliance

Stability Testing

February 17, 2015

The AAHP office just received a copy of an article, Stability Testing of Medicinal Products According to Homeopathic Principles; this appeared in Pharmaceutical Industry (71, Nr. 12). The article was co-written by 8 colleagues of European companies, of which 5 are members, or related to members, of the AAHP. The article addresses the implementation, in…

Deployment of FDA Inspection Resources

January 23, 2015

This content is restricted to AAHP members. If you are a member, please login. If you are not a member, click here.Existing Users Log InUsername or EmailPassword Remember Me  

FDA Establishes Unique Facility Identifier

December 19, 2014

In November, the Food and Drug Administration published a Guidance for Industry entitled: Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration. This guidance is a direct result of the Food and Drug Administration Safety and Innovation Act of July 2012.  Sections 701 and 702 of FDASIA require FDA to specify the…

Assays of homeopathic preparations

December 19, 2014

This content is restricted to AAHP members. If you are a member, please login. If you are not a member, click here.Existing Users Log InUsername or EmailPassword Remember Me  

Two Informative FDA Guidance documents

October 13, 2014

FDA has issued a Guidance for Industry document, ANDA Submissions ― Refuse-to-Receive Standards, which contains helpful hints on the Agency’s thinking and practices. Much of the contents may not be applicable to members of our industry, because homeopathic drug products are, by and large, not subject to the ANDA process, but hidden within the Guidance…

Social Media and Products Subject to FDA Regulation

September 3, 2014

This content is restricted to AAHP members. If you are a member, please login. If you are not a member, click here.Existing Users Log InUsername or EmailPassword Remember Me  

FDA & Proprietary Names

September 3, 2014

FDA has published a draft document on “Best Practices in Developing Proprietary Names for Drugs”. This document is intended to help companies develop product names that do not cause or contribute to medication errorsor otherwise contribute to the misbranding of the drug. With safety in mind, it describes design practices to help avoid such errors…

Homeopathic Quality by Design

September 3, 2014

This content is restricted to AAHP members. If you are a member, please login. If you are not a member, click here.Existing Users Log InUsername or EmailPassword Remember Me  

Unseen Plant Contaminants In Raw Materials

June 4, 2014

This content is restricted to AAHP members. If you are a member, please login. If you are not a member, click here.Existing Users Log InUsername or EmailPassword Remember Me  

Status of English vs. Latin Names of Homeopathic Ingredients

January 24, 2014

The following is the text of letter from FDA to the HPCUS regarding the use of Latin names on Homeopathic drug products.

Leave a Comment

You must be logged in to post a comment.