AI Drug Adherence | Gambline | Immunotherapy | Drug-Stents

Abstract. Governments and financial institutions in several jurisdictions are planning or implementing nonmedical/‘forced’ switches by cutting drug coverag

BioStudies – one package for all the data supporting a study

Oxandrolone is an androgen and synthetic anabolic steroid (AAS) medication to help promote weight gain in various situations, to help offset protein catabolism caused by long-term corticosteroid therapy, to support recovery from severe burns, to treat bone pain associated with osteoporosis, to aid in the development of girls with Turner syndrome, and for other indications. It is taken by mouth. It was sold under the brand names Oxandrin and Anavar, among others.

Interchangeability Interchangeability is defined by statute in the United States to mean that the product may be substituted for the reference product without the intervention of the physician who prescribed the reference product. The legal standard for interchangeability is an additional standard beyond demonstration of biosimilarity. According to guidance issued by the FDA in May 2019, in order for a biological product to be deemed interchangeable, the information submitted must be sufficient to show that: The biological product is biosimilar to the reference product and can be expected to produce the same result as the reference product in any given patient For a biologic product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch Substitutions In the United States, although Federal law gives the FDA authority to license biologic products as interchangeable, it is the state laws that govern the substitution of biologics and pharmaceuticals.

NCSL’s experts are here to answer your questions and give you unbiased, comprehensive information as soon as you need it on issues facing state legislatures. We answer more than 20,000 requests for information a year.

On May 10, 2019, the Food and Drug Administration issued highly anticipated final guidance that gives drug-makers more clarity on how to demonstrate that a proposed biosimilar product meets the statutory interchangeability standard under the Public Health Service Act (PHS Act or the Act). According to the Act, an interchangeable biosimilar may be substituted for the original biological product without the involvement of a prescriber, similar to the way generic drugs are routinely substituted for brand name drugs at the pharmacy level. The Final Guidance, entitled “Considerations in Demonstrating Interchangeability with a Reference Product,” is shorter than the draft version released over two years ago, in response to industry feedback, but generally tracks the original policy positions proposed in the draft, with a few notable exceptions summarized below.

Interchangeability Interchangeability is defined by statute in the United States to mean that the product may be substituted for the reference product without the intervention of the physician who prescribed the reference product. The legal standard for interchangeability is an additional standard beyond demonstration of biosimilarity. According to guidance issued by the FDA in May 2019, in order for a biological product to be deemed interchangeable, the information submitted must be sufficient to show that: The biological product is biosimilar to the reference product and can be expected to produce the same result as the reference product in any given patient For a biologic product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch Substitutions In the United States, although Federal law gives the FDA authority to license biologic products as interchangeable, it is the state laws that govern the substitution of biologics and pharmaceuticals.

Neurological diseases, particularly in the context of aging, have serious impacts on quality of life and can negatively affect bone health. The brain-bone ax...

Jeffrey Janus, the Director, Senior Vice President Operations ISCO; CEO of Lifeline Cell Technolog of International Stem Cell Corp, made $578,258 in total compensation during 2011, according to salary benchmarking data.

Myocardial stents (both bare metal and drug-eluting varieties) are widely utilized to prevent restenosis following percutaneous transluminal coronary angioplasty (PTCA) and coronary intervention (PCI). Indeed, by 1999 myocardial stents were...

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Abstract. Summary: ROCR is a package for evaluating and visualizing the performance of scoring classifiers in the statistical language R. It features over

Complement is a complex innate immune surveillance system, playing a key role in defense against pathogens and in host homeostasis. The complement system is ...