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Drug & Device News
To Address Shortages, FDA Allows Import of Unapproved Cancer Drugs
Responding to concerns that supplies of certain cancer treatment drugs had become dangerously short, the U.S. Food and Drug Administration (FDA) took steps in February to address the crisis; the agency temporarily authorized the import of two unapproved medications. The FDA announced it would allow the importation of the drug Lipodox (doxorubicin hydrochloride liposome injection), manufactured by India's Sun Pharma Global, to replace Doxil (doxorubicin hydrochloride liposome injection). Doxil, which is commonly used to treat certain ovarian cancer patients and patients with AIDS-related Kaposi's sarcoma or multiple myeloma, became scarce after the drug's manufacturer shut down production at its Ohio facility late last year. The FDA, which in rare emergency circumstances allows the importation of unapproved drugs that are critical to patients, expects the Lipodox imports to meet all U.S. patient needs.
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Law Firms are Reducing Redundant Real Estate by Bringing Support Services Back to the Office
A trend analysis of the benefits and challenges of bringing back administrative, word processing and billing services to law offices.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
Bit Parts
Summary Judgment Denied Defendant in Declaratory Action by Producer of To Kill a Mockingbird Broadway Play Seeking Amateur Theatrical Rights
Risks of “Baseball Arbitration” in Resolving Real Estate Disputes
“Baseball arbitration” refers to the process used in Major League Baseball in which if an eligible player's representative and the club ownership cannot reach a compensation agreement through negotiation, each party enters a final submission and during a formal hearing each side — player and management — presents its case and then the designated panel of arbitrators chooses one of the salary bids with no other result being allowed. This method has become increasingly popular even beyond the sport of baseball.
Disconnect Between In-House and Outside Counsel
'Disconnect Between In-House and Outside Counsel is a continuation of the discussion of client expectations and the disconnect that often occurs. And although the outside attorneys should be pursuing how inside-counsel actually think, inside counsel should make an effort to impart this information without waiting to be asked.