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     · •Generics QbR Deficiencies • Container closure attributes to ensure product quality • Studies to identify necessary attributes including identity, suitability (safety,protection, compatibility, and performance) consistent with the QTPP • Dosage form compatibility (e.g. extractables, leachables, dye from labeling) • Compatibility with the sterilization procedure

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  • Drug Prevention AbuseDrugAbuse

     · Drug prevention programs are designed to provide the education and support necessary to diminish drug dependency in communities, schools and the workplace. Drug abuse prevention has become an important first step in informing specific individuals about the dangers of addiction, prevention techniques and where to find recovery help if it should be deemed necessary. The []

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  • How the Taliban Gets Its Cash HuffPost

     · Afghanistan imports approximately two billion dollars of Western cigarettes a year, an amount that seems disproportionately high given that only about 20% of inhabitants smoke. In addition, local cigarettes sell for around 30 cents a pack, one-third of the price of Western cigarettes. Western cigarettes cost around a dollar a pack in Afghanistan.

  • Medical Devices, Drugs Sidelined in Anti-Kickback

     · The exclusion for drug and medical equipment manufacturers may not be permanent. The HHS wants to study the issue and figure out which types of devices, drugs, or companies should get an exemption. The device industry officials say they expect to get some type of safe harbor in the final rule.

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    Today, drug abuse is highly linked to the spread of HIV/AIDS and to drug-related crimes in China. To combat the severe drug problem facing the nation, the Chinese government has adopted the Methadone Maintenance Treatment program, a multi-faceted therapeutic approach that aims to reduce the health and social problem induced by drug epidemics.

  • Defective Drugs & Medical Devices Injuries, Risks and

     · Medical device manufacturers issued 1,267 product recalls affecting more than 441 million individual devices in 2018, according to Stericycle Expert Solutions, a tech firm that tracks consumer recalls. Software issues were the most common reason behind medical device recalls, accounting for

  • Q&A pharma & medical device regulation in South Korea

     · A Q&A guide to pharma & medical device regulation in South Korea, covering the healthcare bodies and competent authorities, marketing authorisation, defective and

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  • COVID-19 is changing the route of illicit drug flows, says

    COVID-19 is changing the route of illicit drug flows, says UNODC report. Vienna (Austria), 7 May 2020Measures implemented by governments to curb the COVID-19 pandemic have led to drug trafficking routes by air being disrupted, along with drastic reduction or increased interdiction in

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  • Government-Protected ‘Monopolies’ Drive Drug Prices

     · The “most important factor” that drives prescription drug prices higher in the United States than anywhere else in the world is the existence of government-protected “monopoly” rights for

  • CFDA Releases Groundbreaking Drug and Device Policies

     · Food, Drugs, and Devices . On May 11 and 12, 2017, the China Food and Drug Administration (“CFDA”) published drafts of four proposed policies in the form of circulars (or notices) for public comment. These “Proposed Policies” include significant reforms in the areas of the new drug and device approval process

  • Drug and Medical Device Registration FAQ

     · drug, medical device or API inventory has been accounted for, reclaimed and/or disposed of properly. • For each new out-of-state location, attach a copy of the resident state wholesale license.


     · 1 1 The following additional definitions applicable to this Act are provided for in other Acts Butter. The Act of March 4, 1923 (21 U.S.C. 321a), defines butter as ‘‘the food product usually known as butter, and which is made exclusively from milk or cream, or both, with or without

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     · Mexican drug cartels are leading suppliers of cocaine, heroin, methamphetamine, and other illicit narcotics to the United States. The cartels and the drug trade fuel rampant violence in Mexico

  • BfArMHomepage

    2 days ago · The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health.

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  • Patent protection strategiesPubMed Central (PMC)

    Patent protection and the market exclusivity that comes with it help to ensure a return on investment. A patent holder has the right to exclude others from making, using, and selling the patented invention for a defined period. Therefore, patented drugs are temporarily safe from the competition of generics, often resulting in substantial revenues.

  • Federal Institute for Drugs and Medical Devices Global

    Federal Institute for Drugs and Medical Devices. The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health. At the BfArM , roughly 1,000 employees are involved in licensing, improving the

  • Why Patent Protection In The Drug Industry Is Out Of

     · In the United States, the patent protection process as it relates to the drug industry has been distorted by the political system, intense lobbying and large campaign contributions. The result has

  • Orphan Designation System in Japan

    Orphan Drug/Device Designation Procedure Required data (for drugs) Objective statistical data on the number of patients who will use the drug in Japan Indication (e.g., cause and symptoms) Current clinical situation, such as the availability of similar drugs or treatment