Articles

FDA’s Electronic Filing System for Facility and Drug Registrations

January 24, 2014

On October 23, 2008 the FDA released its draft guidance on the new electronic submission system for drugs and establishment registrations.

Homeopathic Industry Perspectives — Can More Be Better?

January 24, 2014

Natural products’ consumers now have more choices than ever in the homeopathic medicinal category.

Finished Product Testing

January 24, 2014

Current Good Manufacturing Practices (cGMPs) require manufacturers of homeopathic drug products to establish finished product specifications and to ensure product quality by testing products for conformance to specifications prior to release.

FDA Requirements for Final Product Testing: Current State of Regulation and Implications for the Industry

January 24, 2014

Final Product Testing of drug products has been a fixture in Title 21 of the Code of Federal regulations. Since the outset, this requirement has caused some difficulty for the manufacturers of homeopathic drug products (HDPs) since the final drug concentration in the final homeopathic dosage form often fell below the limits of measurement.

History and Current Status of Homeopathic Drugs and the Mass Market

January 24, 2014

It goes without saying that the status of homeopathic OTC drugs sold on the mass market has drastically changed in the past two decades. In fact, in the early 1990s there were virtually zero homeopathic products sold in drug, grocery and mass merchandise stores.

OTC & Dietary Supplement Combination Products

January 24, 2014

In 2008, the Tan Sheet reported that Bayer had received warning letters reinforcing the FDA’s ban on Supplement/Drug Combination products stating that the two Bayer HealthCare products combining aspirin with dietary supplements are unapproved new drugs.

Kids Are Number ONE with Homeopathy

January 24, 2014

Do you worry about your child suffering from painful recurring earaches and diarrhea during the flu season? Did you know that homeopathy with its rich history and many kid friendly dosage forms, offers help and hope by triggering the body’s own defenses and without causing side effects?

Homeopathy and ‘The Memory of Water’

January 24, 2014

The July 2007 issue of Homeopathy; The Journal of the Faculty of Homeopathy, is a special issue devoted entirely to the science and commentary surrounding investigations of homeopathic remedies and the theories of water memory as an explanation for homeopathic potencies.

Don’t Skip the Mint

January 24, 2014

Peppermint is one of the oldest and most widely used herbal remedies.

The Current Regulatory Status of Veterinary Homeopathic Drugs in the United States

January 24, 2014

Homeopathic medicines have been classified as drugs in the United States since their inclusion in the Federal Food, Drug, and Cosmetic Act of 1938 (FFD&CA).

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