Regulatory/Legislation

What About Your APIs and Q7 Requirements?

January 26, 2017

By Eric L. Foxman, R.Ph. Jan. 26, 2017 In September 2016, the U.S. Food and Drug Administration (FDA) issued a guidance document, entitled Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients—Guidance for Industry. The document applies to the manufacture of Active Pharmaceutical Ingredients (APIs) for use in human drug products and closely follows a…

Regulatory Policy Analysis

January 4, 2017

A Tool for Evaluating the  Regulatory Framework for Homeopathic Drug Products By Mark Land, AAHP President Today the combination of drug regulations, approval options, cost controls and societal health care goals yield outcomes that are no longer obvious or predictable. So complex is the process that the field of regulatory science emerged to address the…

Who Regulates Your Product Labels?

January 4, 2017

Does the U.S. Food and Drug Administration (FDA) regulate homeopathic product labels? Or does the U.S. Federal Trade Commission (FTC)? Is it both? While most members of the homeopathic industry have long understood that the FDA is responsible for over-the-counter (OTC) drug labels and labeling and the FTC is responsible for OTC drug advertising, the…

A Trump Administration and a Republican-Controlled Congress

January 4, 2017

An Assessment and Outlook of the Political and Regulatory Climate for 2017 By Pete Evich, AAHP government relations January 1, 2017 The election of Donald Trump and a Republican-controlled Congress will mark a change from the “divided government” norm that has reigned over Washington during the last six years. While the new political environment will…

U.S. Senator Bob Casey to Attend Event Sponsored by Keystone State-Based AAHP Members

October 6, 2016

Executives from AAHP member companies that reside in Pennsylvania will be hosting a political event on Tuesday, Oct. 25 for one of their home state senators, Sen. Bob Casey (D). The event, which will be held at the Hyland’s Foundation Library in King of Prussia, Pa. from noon to 1:30 p.m., will be a tremendous…

FTC Holds Workshop on Consumer Disclaimers

October 5, 2016

The complexity of developing and delivering product disclosures to consumers was the subject of a day-long workshop hosted by the Federal Trade Commission (FTC) on Sept. 15 in Washington, DC. While the advent of new technology like cell phones and tablets has created new technical challenges, the FTC has been interested in disclosures for most…

US FDA Establishment Inspections: Outcomes for Labelers for Homeopathic Drugs

June 28, 2016

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Understanding OTC Monograph Reform: Where Do We Stand Now?

June 27, 2016

By J.P. Borneman, Ph.D. and Alvin J. Lorman, J.D. The FDA’s Over-the-Counter Drug Review (OTC Review) has always been important to homeopathy, despite the fact that homeopathic drugs are not directly subject to the review. FDA specifically excluded them in 1972, stating that it would review them separately at the conclusion of the allopathic OTC…

FDA Guidance for Industry – Request for Quality Metrics

June 2, 2016

By Mark Land, AAHP President FDA published its draft guidance, Request for Quality Metrics; Guidance for Industry1. Advancing the background on the initiative in general, this draft reveals 10 mandatory metrics emanating from manufacturing and laboratory systems. It also requests comments on three optional metrics: 1) senior management engagement, 2) the corrective and preventative actions…

Educational Webinar Resources Available

June 25, 2019

Missed an education opportunity? Need materials for your mandated employee training? You have a second chance! AAHP webinars can help fulfill your required mandatory staff training requirements. Homeopathic manufacturers and marketers have found AAHP to be an excellent third-party source for this training.   All DVD’s include an MP4 recording of the webinar, an MP3…

AAHP monitors and reports on current federal regulations, legislation and government policies that affect the homeopathic community. AAHP is often the first to learn of regulatory changes that have both direct and indirect effects on our industry enabling members to stay ahead of the curve in a rapidly changing healthcare environment.

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