Articles

Recall Trends 2Qtr 2014

October 13, 2014

Each quarter, Stericycle produces a summary report of recalls affecting several industries, including the overall Pharma category. With snapshot graphics, the report notes that Pharma recalls are inching steadily upwards.…

AAHP Semi-Annual Meeting

September 3, 2014

The AAHP’s Semi-Annual Meeting will be held Friday, September 19 in Baltimore, MD at 9am. We will meet in the Holiday Inn, Inner Harbor at 301 West Lombard Street, just…

Social Media and Products Subject to FDA Regulation

September 3, 2014

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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…

Homeopathic Quality by Design

September 3, 2014

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When is a Homeopathic Product OTC or Rx ?

January 27, 2014

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

January 24, 2014

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

January 24, 2014

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

January 24, 2014

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

January 24, 2014

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.

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