Archive for the 'Regulatory Affairs / Drug Approvals' Category


FDA Takes Legal Action Against Dietary Supplement Maker In Pennsylvania

The FDA has for the first time taken legal action against a dietary supplement manufacturer and owner, which has substituted ingredients and products and failed to note the changes on the final product labels. The U.S…


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Marijuana: A Real Volume Business, $1.7 BILLION Dollar Med Market

Medical marijuana is now a serious $1.7 billion dollar market, according to a new report released this week by an independent financial analysis firm that specializes in new and unique markets. Currently, 24.8 million people are eligible to receive a recommendation and purchase marijuana legally under state laws, and approximately 730,000 people actually do…


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Dangerous Supplement Likened To Industrial Bleach, UK Consumers Warned

The Food Standards Agency (FSA) is urgently warning UK consumers about a supplement described as "equivalent to industrial strength bleach" and that if used as directed can cause severe nausea, vomiting and diarrhea...
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ISO20072 Ready Specification Allows For Rapid Customisation And Development Of Inhalers, Enabling A Faster Route To Market

Cambridge Consultants has released its latest Dry Powder Inhaler (DPI) generic specification to address recent regulatory requirements and technological developments, helping speed up the development process and time to market for inhalation devices.
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Four Innovative Novartis Medicines For Cancer, Asthma, High Blood Pressure And Wet AMD Approved In Japan

Patients in Japan stand to benefit from the approval of four innovative medicines - Tasigna® for the treatment of a life-threatening form of leukemia, Xolair® for severe asthma, Co-Dio® for high blood pressure, and Lucentis® for wet age-related macular degeneration (AMD), an eye disease that is a major cause of blindness in people over the age of 50 in Japan.
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China Recalls Ginseng Injections After 3 Deaths

A chinese pharmaceutical firm recalled batches of ginseng herbal injections after three people given the treatments died, said a local authority announcement on Thursday in Kunming in southwestern Yunnan Province of China. According to China state news agency Xinhua, the Yunnan Provincial Health Department said the two recalled batches of "ciwujia" (a type of Siberian ginseng) injections have been tested and no toxins were found.
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Feds Target Bogus Cancer Cures

The Federal Trade Commission (FTC) in the United States is cracking down on companies and individuals who through deceptive advertisements say their products cure or treat cancer while offering either no proof, or quoting false clinical evidence in support of their claims. The FTC said it had invoked 11 law enforcement actions under the FTC Act that bars deceptive claims.
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Why Strawberry Jam Is More Regulated Than Cigarettes

While jams and other consumer products are strictly regulated and are required to pass stringent tests before they can be sold, tobacco has no restrictions and manufacturers can, and do, add anything they want into the product. Published in
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