107 results about "Fda approval" patented technology

The invention is directed to a ready-to-use modular cleanroom and facility, in particular for the production of drugs and biological substances, which is equipped with pre-approved manufacturing equipment cores. The modular cleanroom is implemented in the interior space of a container, such as a standard shipping container, and includes at least one bioreactor station. The modular facility can be installed on-site from pre-approved cleanroom modules without further regulatory approval. The cleanroom and facility comply with FDA-approved good manufacturing practices (GMP) and good laboratory practices (GLP).

A surgical retractor and a method of minimally invasive surgery, wherein the surgical retractor includes ribs and a mechanism for microns-resolution transferring of linear and rotational movements of the ribs and wherein each rib can be easily replaced without use of any additional tools.

According to an embodiment of the present invention the transmission is simpler. Likewise, an auxiliary handle is added to facilitate the insertion of the ribs into the body of the operated patient, and the vast majority of components of the surgical retractor are made with biocompatible, and FDA approved material ULTEM HU 1000 RESIN transparent (radiolucent) to X-ray radiation and are designated for single use.

A reusable bag (10) made of materials, such as an FDA approved food-grade silicone, which may or may not include fillers, that can withstand the extreme temperatures used in the entire food preparation, cooking, and cleaning processes, including, but not limited to, storing, freezing, defrosting, marinating, baking, and washing for reuse. The bag (10) may be seamless and may have rounded corners and/or a rounded bottom (14), which allows for reversibility for the purpose of cleaning and prevents the accumulation of food, bacteria, or other contaminants thereby ensuring the safety and reusability of the invention. This bag may be closed and opened repeatedly by a sealing mechanism (12) that allows for an air and water tight seal.

Concentrated, low-viscosity, low-volume liquid pharmaceutical formulations of proteins have been developed. Such formulations can be rapidly and conveniently administered by subcutaneous or intramuscular injection, rather than by lengthy intravenous infusion. These formulations include low-molecular-weight and/or high-molecular-weight proteins, such as mAbs, and viscosity-lowering agents that are typically bulky polar organic compounds, such as many of the GRAS (US Food and Drug Administration List of compounds generally regarded as safe) and inactive injectable ingredients and FDA approved therapeutics.

Modified or extended release formulations containing mesalamine compounds and associated methods are disclosed and described. In some aspects, such formulations may be substantially bioequivalent to known FDA approved mesalamine formulations such as PENTASA®.

A system and method for rapid entry of past medical diagnoses allows for development of specific, clinically relevant diagnoses from a simple input medication through use of a developed database that maps an input medication to a specific medical diagnosis through an intermediate indications data set. Input medications are normalized to their generic or chemical name and the normalized medication data is associated to an intermediate diagnosis through a medications indications listing contained in a database. Each medication develops a short list of possible specific and/or macro-diagnoses (indications) consistent with the medications and a selected indication is concept-matched to a specific medical diagnosis in order to develop a proper diagnosis in clinically meaningful terms, from a concept-mapped portion of the database. The concept-mapped portion is developed by grouping medical terms into clinically meaningful groups and developing pointers within those groups between identified diseases and a developed indications taxonomy, itself developed by forming a composite of FDA-approved and non-FDA approved indications with respect to particular normalized medications.

The present invention relates to lap trays, specifically to non-rigid automobile lap trays with four surrounding high sides, constructed from FDA-approved materials for safe contact with food, having properties available to withstand temperatures greater than 200° F. The non-rigid automobile lap tray is formed through one of several processes: they can be compression molded or transfer molded if a rubber or silicone material is used, or injection molded with non-rigid plastic materials.

A copolymer Tradenamed HexiLok is applied in the form of an ink as a decorative and protective outer covering to glassware and other tableware. It serves also as an adhesion coating to which a cross-linked ethylene acrylic acid copolymer is applied, to serve as a shock absorber and shard retention agent, in the event of breakage of the wares. The impact resistance of drinking glasses can be improved ten-fold with a 5 mil outer coating. The use of UV light as a curing agent in a 2-stage curing process, enables high production rates. The tough HexiLok ink serves to hermetically seal the decorated surface of the wares, enabling the use of non-FDA approved decorating agents.

The present invention relates to a system and method for electronic and algorithmic data mining of an individual physician's prescribing history to determine the approximate distribution of diseases within their practice population for optimizing pharmaceutical sales and marketing. Rapid and large-scale determination of specific clinical safety and efficacy attributes of a marketed drug which are most pertinent and relevant to a given physician, when compared to a competitor's drug, are defined and tabularized. Major clinical characteristics taken into account include a drug's safety, efficacy, cost, dosing convenience, formulary insurance coverage, side effect profiles, and FDA approval for the intended use. A symbolic representation of knowledge is employed in which the marketed drug and each competitor's drug are compared algorithmically against each other with a scoring system that is based upon machine analysis of each major clinical characteristic. The score is further refined according to the number and severity of safety interactions which are relevant to the comparison, and also based upon predicted prevalence of such interactions within a specific physician's practice.

The invention provides a cationic polymer-loaded paclitaxel/indocyanine green (ICG) co-delivery micelle and a preparation method thereof. To simultaneously load the chemotherapeutic paclitaxel and the photosensitizer ICG, an amphiphilic degradable cationic nano-micelle MPEG-PCL-PEI is used as a loading medium for the chemotherapeutic paclitaxel; a cationic polymer block is introduced into a polymer MPEG-PCL which forms the nano-micelle, so surface charges of the micelle can be changed; negatively-charged ICG molecules are adsorbed through interaction between positive and negative charges, and sustained release of paclitaxel and ICG is realized; so a novel method is provided for integrated diagnosis and treatment of tumors. According to the invention, the triblock cationic polymer synthesized from an amphiphilic polymer-grafted cationic fragment can simultaneously load the chemotherapeutic paclitaxel and the photosensitizer ICG approved by FDA, so compounding of the chemotherapeutic and fluorescence molecules is realized, and fluorescent imaging of a tumor site as well as target drug delivery for a tumor is complished.

There is provided a method of manufacturing a paper-forming product formed of an environmentally friendly paper coating agent, which is excellent in water resistance, oil resistance, thermally adhesive property, and alkaline water-dissociative property, the method including mixing alkali metal hydroxide, amines, ammonia water, or the like with each of an ethylene-acrylic acid copolymer or an ethylene-(meth)acrylic acid copolymer or a mixture of these polymers, and using a water-dispersible coating solution prepared by adding FDA-approved matting agent, slip agent, and anti-foaming agent into a water-dispersible resin solution prepared by neutralizing the mixed product in an aqueous medium.

The invention discloses a growth factor nanotube slow-release system used for osseointegration and a preparation method and application thereof, the nanotube slow-release system includes a titanium alloy implant, a titanium dioxide nanotube coating is prepared on the titanium alloy implant surface by the method of anodic oxidation, and the titanium alloy implant is loaded with a growth factor. The growth factor nanotube slow-release system has the advantages that: (1) the growth factor nanotube slow-release system can improve the nanotube drug loading amount by a simple and effective method of vacuum aspiration; (2) the invention also provides a rhPDGF- BB nanotube slow-release system which can significantly promote the osseointegration in bone osteoporosis state, rhPDGF-BB is approved by the FDA to be used in clinical osteanagenesis therapies, and clinical application of the nanotube slow-release system may be provided; and (3) including nanotube preparation, therowth factor nanotube slow-release system is in no need of special, complex and expensive equipment, simple in operation process, and conducive to the promotion and use.

Apparatus and process for stretch wrapping articles, especially heads of lettuce, wherein a roll (23) of film (24) is supported on a housing (21), and the film is supplied from the roll around a dancer roller (50) and film feed roller (51) to a pair of film feed grippers (33, 34) which grip a leading edge of the film and advance it past an opening (26), whereupon a clamp (27) engages the leading edge of the film to hold it while the grippers release and return to their home position. Additional clamps (28-32) then engage the film to hold it in place over the opening. A head of lettuce (L) is placed on the film in centered relation to the opening, and a ram (37) engages the lettuce and pushes it against the film to stretch the film through and below the opening. Gathering bars (38, 39) engage the film stretched between the opening and the head of lettuce to gather the film in a first direction, and a U-channel (40) and sealing and trimming mechanism (41) gather the film in a second direction to produce a narrow necked down section of gathered film, fuse and seal the necked down section to produce a wrapped head of lettuce, trim excess film from the lettuce, and release the wrapped head of lettuce to drop onto a take away conveyor. The film (24) is a polyethylene based multi-layer film with an outer polypropylene layer for added gloss, slip and clarity, has a 300% stretch capability, is FDA approved for direct food contact, has an anti-fog additive for moisture dissipation during temperature fluctuations, is thirteen microns thick, and has a width of sixteen inches.

A domestic pet toy is provided having a housing element formed of a moldable or extrudable catnip composite made of a solid catnip attractant, a lignocellulose cork agglomerate filler material, and an FDA approved binding agent adhesive. The housing material provides sufficient delivery aromatic olfactory attractant to be effective in having an interactive response with a domestic feline. A sound chip assembly can also be positioned in a retention cavity and emits a prerecorded sound as an audible attractant in response to one or both of commencement and continuation of movement the pet toy.

A nano-capsule construct for imaging and therapeutic uses and method for production are provided. One nano-probe embodiment based on genome-depleted plant brome mosaic virus (BMV) whose interior is doped with indocyanine green (ICG), an FDA-approved near infrared fluorescent dye, is used to illustrate the invention. The material encapsulated in viral shell components may be coated with functionalized coatings such as branched, dendritic polymer coatings to improve longevity and distribution in the body as well as antibody conjugation for increased target specificity. The constructs can also be coated with ferromagnetic iron oxide nanoparticles, enabling the ICG-containing capsules to be used as nano-probes with the capability of being detected in both optical and magnetic resonance imaging. The capsules may be produced by purifying a plant or animal viruses and disassembling the viruses to provide virus shell components. The virus shell components are reassembled in the presence of a material for encapsulation thereby encapsulating said material within the core of the construct in one embodiment.

The invention discloses application of cobimetinib in preparation of medicaments for treating tuberculosis. The application is high in safety, and the efficiency of killing mycobacterium tuberculosisis high. According to the application of cobimetinib in preparation of the medicaments for treating tuberculosis, the medicaments for treating tuberculosis are resistant to mycobacterium tuberculosis.The invention also provides a pharmaceutical composition for treating tuberculosis. The pharmaceutical composition comprises cobimetinib. Cobimetinib serving as a potential medicament for targeting HDT has been approved by FDA, is high in safety and has a great development value, so that by applying cobimetinib as a main component in anti-tuberculosis medicaments, the safety is high. Experimentsshow that cobimetinib in macrophages can obviously enhance the activity of the macrophages to kill tubercle bacillus.

The present invention provides a therapeutic approach to maintain and expand HSCs in vivo using currently available medications that target GSK-3 and mTOR. The present invention also provides a system and method for the ex vivo culturing of HSCs, where an mTOR inhibitor is combined with a GSK-3 inhibitor within the culturing conditions.

The invention relates to application of Lenvatinib to preparation of medicine for preventing and curing macular degeneration, and belongs to the field of medicine. The problem that the conventional therapeutic medicine for macular degeneration is low in curative effect and low in patient compliance is solved, and the technical scheme is to provide application of Lenvatinib to preparation of medicine for preventing and curing macular degeneration. Lenvatinib is a multiple target point micromolecularly targeted inhibitor resist to VEGFR, PDGFR and bFGFR, and has been approved by FDA in the market for the treatment of tumors. The invention shows that Lenvatinib has potential for curing macular degeneration, and the application of Lenvatinib is verified by establishing an in vitro and vivo evaluation model, and the application has preferable clinic and social meanings.

A method for the removal of mycotoxins from cereal or oil seed meal that includes the use of a mycotoxin sequestrant to form a food grade composition for human consumption wherein said composition contains no more or less than an FDA approved level of mycotoxin for a human food product.

The invention provides a coating for drinking water tube/container liners, a preparation method and a construction method, which can solve the problems in the prior art, such as toxicity and low construction efficiency, etc. The coating of the invention contains no solvent, and all the pigments and auxiliaries pass the FDA approval. Through detection, the products pass the BS6920 standard absolutely and can be safely applied to the drinking water duct liners. Meanwhile, the coating of the invention features rapid curing rate, convenient and fast construction and thick one-time forming film, and is extremely suitable for large-scale drinking water duct construction.

A cooking oil filtration system for a cooking apparatus wherein organic contaminants suspended in hot cooking oil are separated and trapped in/on a hollow cylindrical filter made of high temperature food grade and/or FDA approved polymer material as the hot cooking oil is pumped through a filter housing fluidly connected to a cooking oil reservoir. A fryer basket with walls and a bottom constructed of fine wire mesh provide surface filtration of organic contaminants suspended in the hot cooking oil before passing through the filter housing.

A natural liquid composition is provided for disinfectant, antibacterial or anticorrosion applications. The natural liquid composition is an electrospun solubilized composition of natural chitosan (CS) and an FDA approved polymer polyvinyl alcohol (PVA). Two fillers, citric acid (CA) and ascorbic acid (AA), added anti-corrosion property to the composite nanofiber solution without affecting the other properties (disinfectant and antibacterial) and have a final synergistic effect of all components together in a final solution form. Embodiment of the invention advances the art by providing a natural solution to overcome at least some of the problems with the currently used agents.

The invention belongs to the field of biological medicine, and relates to a long-acting HIV fusion inhibitor for treating acquired immune deficiency syndrome and application thereof. The long-acting HIV fusion inhibitor comprises a polypeptide part for inhibiting HIV membrane fusion and a part capable of being specifically combined with human immune globulin Fc, it is proved through experiments that the half-life period of the long-acting HIV fusion inhibitor in a rhesus monkey is about 11 times that of the HIV fusion inhibitor T20 which is first approved for marketing and has excellent antiviral activity to HIV-1IIIB and HIV-1Bal, the IC50 values are about 5.9 nM and 2.57 nM respectively, the antiviral activity is about 3 times that of T20, and the long-acting HIV fusion inhibitor has low toxicity to cells. The long-acting HIV fusion inhibitor IBP-CP24 polypeptide can be used for preparing a drug for resisting human immunodeficiency viruses for a long time and providing a new strategy for prolonging the half-life period of protein and polypeptide drugs in the body.