Compliance

AAHP Addresses OTC Homeopathic Drug Products for Asthma

March 30, 2015

The American Association of Homeopathic Pharmacists (AAHP), representing the principal manufacturers and distributors of homeopathic medicines in the United States, said today it fully supports the Food and Drug Administration’s position that consumers should seek the advice of their health care provider if they suspect they or their children are experiencing symptoms of asthma, which…

FDA’s Quality Metrics Initiative – From Compliance to Performance

February 17, 2015

By Mark Land, VP Operations and Regulatory Affairs at Boiron The 2012 Food Drug Administration Safety and Innovation Act (FDASIA) gave FDA new tools to encourage high quality manufacturing of pharmaceuticals and enhanced the agency’s ability to respond to, prevent and mitigate the risk of drug shortages. Section 705 of the Act specifically requires FDA…

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  

Leave a Comment

You must be logged in to post a comment.