Adopting orphan drugs - Two dozen years of treating rare diseases

Article Abstract:

The Orphan Drug Act was passed as an amendment to the Federal Food, Drug and Cosmetic Act, while the law defines an orphan drug as one with efficacy against a disease affecting fewer than 200,000 people in the US or one that the scientists. The law has passed, 282 such drugs and biological products providing treatment for more than 14 million patients in the US.

Care and treatment, Chronic diseases, Orphan drugs

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Scientific and legal viability of follow-on protein drugs

Article Abstract:

The article discusses the use of protein-based therapies used today in the treatment of many ailments like diabetes and anemia and how some scientific issues of follow-on protein products still remain unresolved. Also some of the legal issues underlying these follow-on protein products are discussed.

Science & research, Research, Analysis, Drug approval, Protein therapy

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The ongoing regulation of generic drugs

Article Abstract:

The issues related to regulation of generic drugs by FDA approval and compulsory licenses for patented drugs to protect public health or increase access to essential medicines are reviewed.

Pharmaceutical Preparation Manufacturing, Commodity & service prices, Pharmaceutical preparations, Generic Drugs, Prices and rates, Brand name products, Brand names, United States. Food and Drug Administration, Company pricing policy

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