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Regulation of Homeopathic Drug Products
By John P. Borneman and Robert I. Field Purpose The regulation of homeopathic drug products is discussed. Summary Homeopathy is a system of medicine based...
Reading Between the Lines
By Eric L. Foxman, R.Ph. A negative bias of unfavorable reports on homeopathic medicine is an unfortunate and continuing trend. Although numerous studies show measurable...
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...
Third Party Auditors
By Jonathan Priest As in any business, knowing current regulatory standards and your company’s status when compared to those standards is a key to remaining...
FDA Is Paying Attention to Retained Samples—Manufacturers Should Too
By Mary Beth Watkins The retention of reserve samples and their annual inspection records are a routine part of most cGMP inspections by the FDA....
Radio Frequency Identification (RFID) in the Pharmaceutical Supply Chain
By Joerg Zimmer Summary: RFID is a technology that uses radio waves to automatically identify objects. RFID technology can deliver many benefits, from tracking work...
Prudent Use of Special Warnings on Labels?
By Eric L. Foxman, R.Ph. The HPCUS Council on Pharmacy (CoP) has discussed the appropriateness of warning statements for a number of homeopathic substances. The...