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FDA’s Electronic Filing System for Facility and Drug Registrations
By Jonathan Priest On October 23, 2008 the FDA released its draft guidance on the new electronic submission system for drugs and establishment registrations. This...
Homeopathic Industry Perspectives — Can More Be Better?
Natural products' consumers now have more choices than ever in the homeopathic medicinal category. Competition and expansion of homeopathic products and dosage forms has resulted...
Finished Product Testing
by Mary Beth Watkins Summary: Current Good Manufacturing Practices (cGMPs) require manufacturers of homeopathic drug products to establish finished product specifications and to ensure product...
FDA Requirements for Final Product Testing: Current State of Regulation and Implications for the Industry
by Joerge Zimmer and Mark Land Introduction Final Product Testing of drug products has been a fixture in Title 21 of the Code of Federal...
History and Current Status of Homeopathic Drugs and the Mass Market
By Susan De Gress It goes without saying that the status of homeopathic OTC drugs sold on the mass market has drastically changed in the...
OTC & Dietary Supplement Combination Products
FDA Issues ‘New Drug’ Warning Letters In 2008, the Tan Sheet reported that Bayer had received warning letters reinforcing the FDA’s ban on Supplement/Drug Combination...
Kids Are Number ONE with Homeopathy
By Shane Hinze Do you worry about your child suffering from painful recurring earaches and diarrhea during the flu season? Did you know that homeopathy...
