Aerial capsule emergency separation device Patent

Aerial capsule emergency separation device using jettisonable tower

Space Shuttle RCS Oxidizer Leak Repair for STS-26

Following propellant loading of the Space Shuttle's reaction control system (RCS) for mission STS 26, an oxidizer leak was detected in the left orbital maneuvering system (OMS) pod, where the RCS is located. Subsequent investigation determined that the leak was isolated at a mechanical Dynatube fitting near the RCS nitrogen tetroxide tank. An intense effort was initiated to design, fabricate, and qualify a sealing device to stop the oxidizer leak externally so that the Space Shuttle launch could proceed. It was discovered that sealing devices called clamshells were widely used throughout the petrochemical and power generation industries to stop leaks developed in large diameter pipes which carry steam or other hazardous fluids. These clamshells are available in different diameters and strengths and are placed around the pipe at the location of the leak. A sealing compound is then injected under high pressure into the clamshell to stop the leak. This technology was scaled down and applied to the problem of stopping the leak on the Orbiter, which was on a half-inch diameter line in a nearly inaccessible location. Many obstacles had to be overcome such as determining that the sealing material would be compatible with the nitrogen tetroxide and ensuring that the clamshell would actually fit around the Dynatube fitting without interfering with other lines which were in close proximity. The effort at the NASA Johnson Space Center included materials compatibility testing of several sealants, design of a clamshell to fit in the confined compartment, and manufacture and qualification of the flight hardware. A clamshell was successfully placed around the Dynatube fitting on the Orbiter and the oxidizer leak was terminated. Then it was decided to apply this technology further and design clamshells for other mechanical fittings onboard the Orbiter and develop sealing compounds which will be compatible with fuels such as monomethyl hydrazine (MMH). The potential exists for using this type of sealing device in numerous other applications throughout the aerospace industry

Sharp Nash inequalities on manifolds with boundary in the presence of symmetries

In this paper we establish the best constant $\widetilde A_{opt}(\bar{M})$ for the Trace Nash inequality on a $n-$dimensional compact Riemannian manifold in the presence of symmetries, which is an improvement over the classical case due to the symmetries which arise and reflect the geometry of manifold. This is particularly true when the data of the problem is invariant under the action of an arbitrary compact subgroup $G$ of the isometry group $Is(M,g)$, where all the orbits have infinite cardinal

Best constants in the exceptional case of Sobolev inequalities

We prove the existence of a second best constant in the exceptional case of Sobolev inequalities on a compact Riemannian n-manifold locally conformally fla

Why FDCA Section 505(U) Should Not Concern us Greatly

Among the many amendments found in the Food and Drug Administration Amendment Act of 2007 (FDAAA) is a provision at the end of the act, Section 505(u), which grants chiral switches five years of market exclusivity under certain circumstances. Prior to Congressional enactment of the FDAAA, the Food and Drug Administration (FDA) refused to award new chemical entity (NCE) status to enantiomers of previously approved racemic mixtures. The FDA defines a new chemical entity ( NCE ) as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505(b) of the FDCA.3 According to the FDA, NCEs are by definition innovative and represent significant changes from already-approved drug products, such as a new use. Granting five years of market exclusivity to chiral switches mimics the exclusivity accorded to NCEs. This policy change may be rewarding innovation that has either gone unrecognized as patentable by the Federal Circuit or has been recognized as patentable under a unique set of qualifying standards by the Federal Circuit. From this perspective, it may appear as though Congress, by enacting Section 505(u), has somehow done an end-run around the patent system by allowing exclusivity where none has been previously offered. This Comment, however, argues that Section 505(u) will have a limited effect on drug development incentives and generic entrance into the marketplace because the ease with which most racemic mixtures may be resolved and the need for developing safe drugs in the first instance to gain FDA market approval points away from continued development of racemic drugs. In other words, Section 505(u) is time-limited because drug companies today are almost exclusively pursuing single enantiomer drugs

cGMP Violations Should Not Be Used as a Basis for FCA Actions Absent Fraud

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the alleged violation with the government reimbursement under Medicare and Medicaid. cGMP violations, however, are historically enforced by the Food and Drug Administration (FDA) under the Food, Drug, and Cosmetic Act (FDCA), which regulates the safety and effectiveness of drugs and devices. Whether alleged cGMP violations are subject to enforcement by the FDA under the FDCA or by the DOJ and private citizens on behalf of the United States government under the FCA, or both, has been heavily debated recently. This Article examines the statutory background of cGMPs and quality system regulations, considers enforcement of cGMP violations by both the FDA under the FDCA and the DOJ under the FCA, and proposes that fraudulent and felonious violations of cGMPs should be enforced by the DOJ under the FCA because DOJ has the resources and the expertise to investigate and prosecute such violations. Non-fraudulent cGMP violations, on the other hand, should be enforced by the FDA under the FDCA because the FDA has both the subject matter expertise and the statutory mandate to regulate drugs and medical devices

cGMP Violations Should Not Be Used as a Basis for FCA Actions Absent Fraud

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the alleged violation with the government reimbursement under Medicare and Medicaid. cGMP violations, however, are historically enforced by the Food and Drug Administration (FDA) under the Food, Drug, and Cosmetic Act (FDCA), which regulates the safety and effectiveness of drugs and devices. Whether alleged cGMP violations are subject to enforcement by the FDA under the FDCA or by the DOJ and private citizens on behalf of the United States government under the FCA, or both, has been heavily debated recently. This Article examines the statutory background of cGMPs and quality system regulations, considers enforcement of cGMP violations by both the FDA under the FDCA and the DOJ under the FCA, and proposes that fraudulent and felonious violations of cGMPs should be enforced by the DOJ under the FCA because DOJ has the resources and the expertise to investigate and prosecute such violations. Non-fraudulent cGMP violations, on the other hand, should be enforced by the FDA under the FDCA because the FDA has both the subject matter expertise and the statutory mandate to regulate drugs and medical devices

Why FDCA Section 505(U) Should Not Concern us Greatly

Among the many amendments found in the Food and Drug Administration Amendment Act of 2007 (FDAAA) is a provision at the end of the act, Section 505(u), which grants chiral switches five years of market exclusivity under certain circumstances. Prior to Congressional enactment of the FDAAA, the Food and Drug Administration (FDA) refused to award new chemical entity (NCE) status to enantiomers of previously approved racemic mixtures. The FDA defines a new chemical entity ( NCE ) as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505(b) of the FDCA.3 According to the FDA, NCEs are by definition innovative and represent significant changes from already-approved drug products, such as a new use. Granting five years of market exclusivity to chiral switches mimics the exclusivity accorded to NCEs. This policy change may be rewarding innovation that has either gone unrecognized as patentable by the Federal Circuit or has been recognized as patentable under a unique set of qualifying standards by the Federal Circuit. From this perspective, it may appear as though Congress, by enacting Section 505(u), has somehow done an end-run around the patent system by allowing exclusivity where none has been previously offered. This Comment, however, argues that Section 505(u) will have a limited effect on drug development incentives and generic entrance into the marketplace because the ease with which most racemic mixtures may be resolved and the need for developing safe drugs in the first instance to gain FDA market approval points away from continued development of racemic drugs. In other words, Section 505(u) is time-limited because drug companies today are almost exclusively pursuing single enantiomer drugs