News & Analysis as of

Pharmaceutical Industry The United States Food and Drug Administration Innovation

FDA Offers Guidance on Streamlined Development of Treatments for Rare Bacterial Infections

by Knobbe Martens on

On August 1, 2017, the U.S. Food and Drug Administration released its draft guidance titled Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases, detailing proposals...more

FDA Steps Up on Medical Device Innovation

by Mark Mansour on

At long last, FDA has the makings of a coherent and forward-thinking policy to address the widening gap between industry's ability to innovate and FDA's regulatory capacity. Consistent with the mandate of the 21st Century...more

What Does the Cures Act Really Mean for Patients?

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

Court Rejects Theory Of Derivation Based On FDA Requirement

by Foley & Lardner LLP on

The Federal Circuit decision in Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC may be more interesting for what Mylan argued than for what the Federal Circuit decided. However, it could be an important decision...more

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

by Knobbe Martens on

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

Basics of the BPCIA

by Womble Bond Dickinson on

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most...more

Three Pressing Challenges for Personalized Medicine

by Foley & Lardner LLP on

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

by Reed Smith on

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for...more

DIA 2015 Provides Panels on All Types of FDA-Regulated Products with Many Opportunities for Insight and Interaction – Part Two of...

by McGuireWoods LLP on

On the third day, the Center for Biologics Evaluation and Research (CBER) conducted its own Town Hall. CBER Director, Karen Midthun, explained how CBER works proactively to help develop new biological therapies. For example,...more

Law Review Articles That Caught Our Eye

by Reed Smith on

Maybe our motto here at DDLaw should be “we read law review articles so you don’t have to.” Here are a couple of recent ones that looked interesting to us....more

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