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After Recalls, Pharmacies Wonder How Well They REALLY Know Their Subcontractors

Pharmacy compounding has been a very hot topic over the last 12 months. Whether it is news from Capitol Hill regarding possible legislation, regulation from the Food and Drug Administration (FDA) or action by a state board of...more

Apple, Samsung Daubert Docs Should Have Been Sealed, Federal Circuit Rules

The media dubbed it, “The Patent Trial of the Century.” In 2011, Apple sued Samsung, claiming its smartphones and tablets infringed patents for the iPhone and iPad. Samsung counter sued, alleging that Apple’s products...more

A victory for generics suppliers

In late June the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we...more

FDA Issues New Medical Device Reporting Guidance

Device manufacturers should be aware of new issues and policy changes, which include the removal of the "two-year rule" for malfunctions. On July 9, the U.S. Food and Drug Administration (FDA) issued a new draft...more

Supreme Court Rejects ‘Stop-Selling’ Argument in Conflict Preemption Cases

In a 5-4 decision, the U.S. Supreme Court rejected the notion that a manufacturer’s option to stop selling its product resolves preemption concerns raised by conflicting state and federal laws....more

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more

“Food Fraud Database”: a New Tool to Protect Against Tainted Ingredients

Last week, the U.S. Pharmacopeial Convention (“USP”), a scientific nonprofit that sets standards for food ingredients, medicines and dietary supplements enforceable by the Food and Drug Administration, released an updated...more

Pro Te Solutio - Vol. 5 No. 3 August 2012

In This Issue: - Diversity In Clinical Trials: The Need For Diversity To Ensure Safety And Efficacy - Federal Removal Statutes: A Review Of The Federal Courts Jurisdiction And Venue Clarification Act Of 2011 -...more

Product Liability Risk In Licensing Trademarks With Technology

A Connecticut Superior Court judge has upheld a jury verdict that once again demonstrates the product liability risks faced by trademark licensors, particularly those who license technology as well as their marks. In Hannibal...more

California Publishes New Draft of Informal Green Chemistry Regulations

Yesterday the California Department of Toxic Substances Control (DTSC) convened a Green Ribbon Science Panel (GRSP) to continue work on the state's Green Chemistry initiative. Readers may recall from previous posts that...more

FDA to Increase Criminal Prosecution of Corporate Officials in the Pharmaceutical Industry

In a recently released letter to U.S. Sen. Chuck Grassley (R-Iowa), the Government Accountability Office (GAO) reported the results of its study into the Food and Drug Administration's (FDA) criminal investigation of...more

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