2014 Elections and Effect on Homeopathic Industry

This Month’s Election and the Homeopathic Industry by Pete Evich of van Scoyoc Associates This overview provides a succinct discussion of how the November 4th U.S. Congressional elections may affect committees that matter most to the homeopathic drug industry Even the most casual observers of American politics are aware that Republican candidates fared extremely wellContinue Reading

Recall Trends 2Qtr 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. However, the accompanying text provides some insights into the background of why this may be happening. For instance, “a mislabeling issue could arise from workingContinue Reading

Two Informative FDA Guidance documents

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 GuidanceContinue Reading

Sept ’14 Member Meeting Successes

The AAHP’s Semi-Annual Member Meeting in Baltimore was an unparalleled success with two new highlights capping the event. After an opening welcome by AAHP President Mark Land, the meeting began with an informative roundtable discussion by Al Lorman, Pete Evich and Jay Borneman. Each provided a quick perspective on current challenges facing the industry. AmongContinue Reading

AAHP Semi-Annual Meeting

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 a 5-10 minute walk to the inside of the Convention Center where Natural Products ExpoEast will be happening. Arrive a few minutes early for aContinue Reading

Social Media and Products Subject to FDA Regulation

by Eric L. Foxman The use of the internet and social media promotion has complicated the previously simple review of FDA regulated industries by the Agency. In response, FDA has published a number of guidance documents this year that outline the Agency’s view of approproiate use of social media for product promotion. The first documentContinue Reading

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 errorsContinue Reading

Homeopathic Quality by Design

by Mary Beth Watkins   Quality by Design, the systematic approach to pharmaceutical development and manufacturing, is a now ubiquitous in the pharmaceutical industry and allied industries. You cannot read an industry magazine or article on almost any topic without reading about how QBD applies to every facet of the pharmaceutical manufacturing business. QPD processes,Continue Reading

Homeopathy officially recognized in Belgium

The practice of homeopathy received a legal recognition in Belgium on last month, but at the same time stricter regulations have been imposed on the sector.The federal government gave the green light in July last year, but the Royal Decree was only published in the Staatsblad, the official news letter issued by the Belgian government,Continue Reading

Unseen Plant Contaminants In Raw Materials

A number of plant species have been successfully used as remediation tools for cleaning heavy metal-contaminated soil. Using such plants is an environmentally friendly method that can clean up the soil without causing harm to soil structure or quality. This can be a successful method because these plants naturally “hyper-accumulate” (i.e. take up) the contaminantsContinue Reading