Your NDC Numbers are About to Change

By Eric Foxman, AAHP Secretary FDA has published a proposal that will change the required National Drug Code (NDC) format from 10 to 12 digits. Once finalized, all NDC holders would be required to convert to the new format. Because of the significant burden this may entail, FDA is proposing readm more…

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House and Senate Advance FDA User Fee Reauthorization Bills

By Pete Evich In the month of June, both the House and Senate advanced separate pieces of legislation that reauthorize FDA’s prescription drug, medical device, biosimilars, and generic drug user fee programs for a five-year period. If Congress does not enact legislation by Sept. 30, 2022, all four user fee readm more…

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The Status of Homeopathic Medicinal Products in the European Union

By European Coalition on Homeopathic & Anthroposophic Medicinal Products (ECHAMP)   Homeopathic medicinal products have a strong foundation in the EU law. Specific EU legislation for homeopathic medicinal products has deep roots in their broad use in the Member States. Most Member States officially confirm a market in their country, readm more…

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FDA Seeks Accelerated Drug Approval, DSHEA, Cosmetics Legislative Reforms

By Pete Evich, AAHP Government Relations As part of the President’s FY 2023 Budget proposal, FDA has called upon Congress to take up legislation that would give the agency additional authorities over accelerated approval of drugs and the ability to impose new requirements for dietary supplement makers and cosmetics facilities, readm more…

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The Regulation of Homeopathic Medicines in 2022

By Mark Land, AAHP President   The content in our June 2022 newsletter on regulation turned out quite different than I imagined when we discussed it at an editorial planning committee meeting several months ago. I envisioned the regulatory issue to include several articles from authors around the world, each readm more…

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Regulation of Homeopathic Medicines in Canada

Submitted by David Skinner, Canadian Homeopathic Pharmaceutical Association   Homeopathic medicines (HMs) are regulated in Canada by Health Canada, the federal government department responsible for ensuring the safety, efficacy, and compositional integrity of health care products and medical devices distributed and sold in Canada. Health Canada has formally recognized HMs readm more…

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