ArticleFlorida District Court Issues Key Ruling In Mortgage Foreclosure CasePreviously, Florida appellate courts were strictly enforcing the acceleration requirements in mortgages.United StatesFinance and BankingDuane Morris LLP
ArticleNasdaq Decides to Get SmallIn a HUGE announcement last week, Nasdaq, Inc., the parent company of the various stock exchanges bearing that name, decided the exchanges should no longer be called NASDAQ. Instead, they are "re-branding" as just plain Nasdaq, i.e. initial cap then lower case.United StatesFinance and BankingDuane Morris LLP
ArticleOCC Releases CRA Evaluations for 17 National Banks and Federal Savings AssociationsThe list contains only national banks, federal savings associations, and insured federal branches of foreign banks that have received ratings. United StatesFinance and BankingDuane Morris LLP
ArticleSenate Strikes Down The CPFB Prohibition On Class Action WaiversOn Tuesday, Oct. 24, , the U.S. Senate voted 51-50 to strike down a rule issued by the CFPB that prevented banks, educational institutions and other businesses from including arbitration clauses...United StatesFinance and BankingDuane Morris LLP
Article$125 Million Settlement For Alleged FCA ViolationsIn a settlement with the US DOJ, Kindred Healthcare, Inc., a skilled nursing and long-term care company, has agreed to pay the federal government more than $125 million for alleged False Claims Act violations.United StatesFood, Drugs, Healthcare, Life SciencesDuane Morris LLP
ArticleAnother Healthcare Fraudster ConvictedThe case was brought as part of the Medicare Fraud Strike Force, which operates in nine cities across the country, and has charged nearly 2,000 defendants who have collectively billed more than $6 billion.United StatesFood, Drugs, Healthcare, Life SciencesDuane Morris LLP
ArticleCARES Act Package Ushers In Changes To OTC Drug Review ProcessMost of the hundreds of pages comprising the CARES Act, signed into law on March 27, 2020, concern measures for directly counteracting COVID-19 and assisting those dealing with economic consequences of the pandemic.United StatesFood, Drugs, Healthcare, Life SciencesDuane Morris LLP
ArticleCMS Arbitration RulesCMS has released the final version of a broad-based proposed rule update that will take effect November 28, 2016. United StatesFood, Drugs, Healthcare, Life SciencesDuane Morris LLP
ArticleCould COVID-19 Data Help Medical Device Manufacturers Accelerate The FDA Approval Process?Still, the real-world evidence (RWE) gained about these devices while marketed under the EUA need not be lost with the passing of the pandemic.United StatesFood, Drugs, Healthcare, Life SciencesDuane Morris LLP
ArticleCould Medical Device Manufacturers Accelerate The FDA Approval Process By Using COVID-19 Data?Were it not for these EUAs, these manufacturers would be unable to market their devices, as their FDA applications would still be pending.United StatesFood, Drugs, Healthcare, Life SciencesDuane Morris LLP
ArticleCourt Extends TROs Enjoining Enforcement Of NIH Rate Change Within 22 Plaintiff StatesSince taking office, the Trump Administration has taken steps to reshape the United States' federal funding infrastructure. One such action relates to the National Institutes of Health's ("NIH") rate change.United StatesFood, Drugs, Healthcare, Life SciencesDuane Morris LLP
ArticleDesigning Shelf Space For AlcoholUnder federal tied-house prohibitions, suppliers and wholesalers of alcohol are not allowed to provide money, supplies, services, or things of value to retailers, unless an exception is permitted. United StatesFood, Drugs, Healthcare, Life SciencesDuane Morris LLP
ArticleDiamond Shruumz Shows Why Intoxicating Products Should Be RegulatedRecently, FDA announced issued an alert warning consumers that a brand of ingestible chocolate bars, cones, and gummies called Diamon Shruumz has been linked to a variety of severe heath symptoms...United StatesFood, Drugs, Healthcare, Life SciencesDuane Morris LLP
ArticleDiscovery Ruling In District Of Minnesota May Have Far-Reaching Implications For FCA DefendantsThe FCA creates liability for persons or entities found to have knowingly submitted false claims to the government or having caused others to do so.United StatesFood, Drugs, Healthcare, Life SciencesDuane Morris LLP
ArticleEMTALA Liability ExpandsA new OIG CMP rule effective January 6, 2017 clarifies the liability guidelines for EMTALA violations. United StatesFood, Drugs, Healthcare, Life SciencesDuane Morris LLP
ArticleFDA Estimates For Formal Meetings Show Continued Growth Of Biosimilars In The United StatesAmong the key aspects in the development of a biosimilar product for the U.S. market is taking advantage of formal meetings with the FDA to gain insight on moving a clinical development program for a proposed biosimilar product forward.United StatesFood, Drugs, Healthcare, Life SciencesDuane Morris LLP
ArticleFDA Issues Draft Guidance For Industry Tablet ScoringOn August 31, 2011, the U.S. Food and Drug Administration ("FDA") issued a draft guidance for sponsors of new drug applications ("NDAs") and abbreviated new drug applications ("ANDAs") providing criteria for evaluating and labeling of tablets that have been scored. United StatesFood, Drugs, Healthcare, Life SciencesDuane Morris LLP
ArticleFDA Launches The TEMPO Pilot For Digital Health Devices To Improve Patient Access To TechnologiesThe U.S. Food and Drug Administration has announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, through which FDA...United StatesFood, Drugs, Healthcare, Life SciencesDuane Morris LLP
ArticleFDA Rolls Out Pilot Of New Quality In 510(k) "Quik" Review ProgramOn September 6, 2018, the FDA launched an alternate to the Traditional 510(k) for submitting a Premarket Notification (510(k)).United StatesFood, Drugs, Healthcare, Life SciencesDuane Morris LLP