FDA & Proprietary Names
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
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When is a Homeopathic Product OTC or Rx ?
Homeopathic drug products must meet stringent criteria for labeling and marketing. The specific criteria for Over-the-Counter (OTC) and Prescription drugs are enumerated in the FDA Compliance Policy Guide.
Reading Between the Lines
A negative bias of unfavorable reports on homeopathic medicine is an unfortunate and continuing trend. Although numerous studies show measurable benefits of homeopathy, there are other reports that appear to be simply intended to discredit this 200 year old system of therapeutics.
Adding Value with Intellectual Property
An important aspect of any business is increasing product, brand and company value by developing, executing and maintaining a strong intellectual property (IP) program. This can be especially important in a crowded and competitive market place.
Third Party Auditors
As in any business, knowing current regulatory standards and your company’s status when compared to those standards is a key to remaining in compliance with both regulatory expectations and client expectations. One way to accomplish this comparison is to hire a third party auditor with the appropriate experience and knowledge to provide an independent perspective on the challenges homeopathic companies encounter under FDA regulations and client requirements.
FDA Is Paying Attention to Retained Samples—Manufacturers Should Too
The retention of reserve samples and their annual inspection records are a routine part of most cGMP inspections by the FDA. In the May 31, 2010 Tan Sheet, the publication reported that the FDA had warned Perrigo in a 483 posted May 28th, for failing to annually inspect retained samples.
Radio Frequency Identification (RFID) in the Pharmaceutical Supply Chain
RFID is a technology that uses radio waves to automatically identify objects. RFID technology can deliver many benefits, from tracking work in process to speeding throughput in a warehouse.
Prudent Use of Special Warnings on Labels?
The HPCUS Council on Pharmacy (CoP) has discussed the appropriateness of warning statements for a number of homeopathic substances. The discussion only focused on low attenuations of three substances.
Customs-Trade Partnership Against Terrorism
By Joerg Zimmer and Mark Land Introduction: In direct response to 9/11, the US Customs Service, now U.S. Customs and Border Protection (CBP) challenged the trade community to partner with CBP to design a new approach to supply chain security focused on protecting the United States against acts of terrorism by improving security while simultaneously…